2 Electrical Safety Test Report-MC100 - OCR

Attachment 1 of MEE202002154-02
Informe de prueba emitido bajo la responsabilidad de:
ACCREDITED
Testing Laboratory
TL-700
TEST REPORT
IEC 61010-1
Safety requirements for electrical equipment for measurement,
control, and laboratory use
Part 1: General requirements
Report Number.................................. MEE202002154-01

Date of issue...................................... June 2,2020
Total number of pages...................... 91 pages,see page 3 for list of attachments
ZW-
Testing Laboratory............................. -IEPIN Suzhou Ltckaii |
Address.............................................. Building 4, No.559Fephu Avenue, Wujiang District, Suzhou, China
Applicant’s name.....................................<2bejiang PushKang Biotechnology Co., Ltd.

Address......................................................C408, Science and Technology Innovation Park NO.398, Mahuan
Road, Binhai new Area, 312366 Shaoxing, Zhejiang, PEOPLE’S
REPUBLIC OF CHINA
Test specification:
Standard............................................. EN 61010-1:2010+A1:2019
Test procedure................................... Testing
Non-standard test method................ N/A
Test Report Form No......................... IEC61010JL
Test Report Form(s) Originator.... VDE Testing and Certification Institute
Master TRF......................................... 2017-10-20
Copyright © 2017 IEC System of Conformity Assessment Schemes for Electrotechnical Equipment
and Components (IECEE System). All rights reserved.
This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as
copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from
the reader's interpretation of the reproduced material due to its placement and context.
General disclaimer:
1) The test report is only valid for the sample delivered by client.
2) The test results presented in this report relate only to the object tested.
3) Any erasure or without specific testing seal the report is invalid.
4) This report shall not be reproduced, except in full, without the written approval of EPIN Suzhou Ltd.
5) Please apply for rechecking within 15 days after receiving the report if there is any objection.
Page 2 of 91 Report No. MEE202002154-01
Test item description.........................: Coagulation Analyzer

Trade Mark..........................................:
PUSHKANG
Manufacturer...................................... : Zhejiang PushKang Biotechnology Co., Ltd.
C408, Science and Technology Innovation Park NO.398, Mahuan
REPUBLIC OF CHINA
Model/Type reference.........................: MC100
Ratings.................................................: 220-240 V, 50/60 Hz, 60 VA
Responsible Testing Laboratory (as applicable), testing procedure and testing location(s):
Testing Laboratory: EPIN Suzhou Ltd.

Testing location/ address................................ : Building 4, No.558 Fenhu Avenue, Wujiang District,
Suzhou, China
Tested by (name, function, signature)............ Jason Zhou
Reviewed by (name, function, signature)...: Jesse Zhao
Approved by (name, function, signature)..: Jay Shao
□ Testing procedure: CTF Stage 1:

Testing location/ address................................ :
Tested by (name, function, signature)............:

Approved by (name, function, signature)

Tested by (name + signature)..........................

Witnessed by (name, function, signature).:
Approved by (name, function, signature)..:

Tested by (name, function, signature)...........

Approved by (name, function, signature)..
Supervised by (name, function, signature):
TRFNo. IEC61010 1L
List of Attachments (including a total number of pages in each attachment)
Document Documents included / attached to this report (description) Page

No. No.
1 Photo document 8
2 EN 61010-2-101:2017 test report, Report No. MEE202002154-02 11
Documents referenced by this report (available on request):
Document Documents description Page

Name or No.
No.
1 Risk assessment report according to ISO 14971:2007 17
2 Operating manual 28
TRF No. IEC61010 1L

Test Report History:

This report may consist of more than one report and is only valid with additional or previous issued reports:
Report Ref. No. Item
N/A
Tests performed (name of test and test clause): Testing location:

All relevant tests except as follows: EPIN Suzhou Ltd.
12.3 Optical radiation was not evaluated in this Building 4, No.558 Fenhu Avenue, Wujiang District,
report Suzhou, China
Summary of compliance with National Differences:
[>3 The product fulfils the requirements of IEC 61010-1:2010+A1:2016 except subclause 12.3 which was not
evaluated in this report.
TRF No. IEC61010_1L

EPI n TOK Page 5 of 91 Report No. MEE202002154-01
Copy of marking plate:
Coagulation Analyzer PUSHING

Model: MC100
220V-240V 50/60Hz 60VA
20XX-X
MC1001000 C€
Zhejiang Push Kang Biotechnology Co., Ltd.
Add: C408. Science and Technology Innovation Park NO.398. Mahuan Road, Binhai
new Area. 312366 Shaoxing. Zhejiang, PEOPLE’S REPUBLIC OF CHINA
Warning label
H I!
Packing label
TRF No. IEC61010 1L

Test item particulars:

Type of item ................................................................ Laboratory
Description of equipment function............................ Coagulation analysis
Connection to MAINS supply....................................... Detachable cord set
Overvoltage category.................................................. II
PoLLUTIoN DEGREE........................................................ 2
Means of protection.................................................... Class I (PE connected)
Environmental conditions.......................................... Normal
For use in wet locations............................................. No
Equipment mobility..................................................... Portable
Operating conditions.................................................. Continuous
Overall size of equipment (W x D x H)....................... 270 mm*180 mmx150 mm
Mass of equipment (kg).............................................. 3 kg
Marked degree of protection to IEC 60529................ N/A
Possible test case verdicts:

-Test case does not apply to the test object: N/A (Not Applicable)
- Test object does meet the requirement: P (Pass)
- Test object does not meet the requirement: F (Fail)
Testing:
Date of receipt of test item: March 14, 2020
Date (s) of performance of tests: March 16, 2020 to April 30, 2020
General remarks:
The test results presented in this report relate only to the object tested.
This report shall not be reproduced, except in full, without the written approval of the issuing testing laboratory,
"(see ENCLoSURE #)" refers to additional information appended to the report.
"(see Form A.xx)" refers to a Table appended to the report.
Bottom lines for measurement Tables Forms A.xx are optional if used as record.
Throughout this report a comma / KI point is used as the decimal separator.

Manufacturer’s Declaration per sub-clause 4.2.5 of IECEE 02:
The application for obtaining a CB Test Certificate Yes
includes more than one factory location and a KI Not applicable
declaration from the manufacturer stating that the
sample(s) submitted for evaluation is (are)
representative of the products from each factory has
been provided
When differences exist; they shall be identified in the general product information section.
Name and address of factory (ies): Zhejiang PushKang Biotechnology Co., Ltd.
C408, Science and Technology Innovation Park
NO.398, Mahuan Road, Binhai new Area, 312366
Shaoxing, Zhejiang, PEOPLE’S REPUBLIC OF
CHINA
TRFNo. IEC61010 1L
EPfflf&K Page 7 of 91 Report No. MEE202002154-01
General product information and other remarks:

Description of unit:
The equipment covered in this report is a blood coagulation analyzer which is used to measure one or more
indexes of coagulation and anticoagulation, fibrinolysis and antifibrinolysis.
The equipment is supplied by AC power source and mainly consists of PSU, MCU board, temperature
control system, detection system, brushless DC motor, cooling fan, display unit, printer, etc. See figure below
© Carcasa de plástico, ©Impresora, ©Cubierta superior, ©Pantalla táctil, ©Carcasa metálica inferior, ©Panel metálico
trasero, ©Interruptor de encendido, ©Interfaz LAN, ©Interfaz USB, ®Interfaz RS232, O Entrada del aparato
El equipo proporciona aislamiento básico desde los circuitos principales hasta la carcasa metálica conectada a tierra,
y aislamiento doble/reforzado desde los circuitos principales hasta los circuitos secundarios de voltaje no peligroso.
La fuente de alimentación fue certificada según EN 60601-1, DI/RI se proporciona entre el circuito primario y el circuito
secundario. La condición de funcionamiento de la fuente de alimentación dentro del equipo no excede la condición
certificada; no se considera necesaria ninguna prueba adicional.
El equipo está diseñado con protección de enclavamiento para evitar que el disco giratorio de alta velocidad salga
volando cuando la cubierta superior se abre manualmente durante la prueba. El principio básico de la protección de
enclavamiento es que cuando se abre la cubierta superior del módulo de visualización, el sensor Hall devuelve la
señal de apertura al software. Después de que el sistema de software reciba la señal, finalizará la prueba y mostrará
información de alarma en la pantalla táctil. Una vez activado el enclavamiento, la prueba no continuará incluso si se
vuelve a cerrar la tapa.
El escáner de código de barras no está evaluado según IEC 62471.
El equipo puede funcionar a máx. temperatura ambiente 30 °C y altitud hasta 2000 m.
TRF No. IEC61010 1L

EPiniOK
Report No. MEE202002154-01
Page 8 of 91
Description of model differences:

Single model
Description of special features:

(HV circuits, high pressure systems etc.)
No such special features
TRF No. IEC61010_1L

EPim^K Page 9 of 91 Report No. MEE202002154-01
IEC 61010-1
Clause Requirement + Test Result - Remark Verdict
4 TESTS p
4.4 Testing in SINGLE FAULT CONDITIONS
4.4.1 Fault tests (see Form A.1) p

4.4.2 Application of SINGLE FAULT CONDITIONS p
4.4.2.1 SINGLE FAULT CONDITIONS not covered by 4.4.2.2 to (see Form A.1) p
4.4.2.14
44.2.2 PROTECTIVE IMPEDANCE N/A
44.2.3 PROTECTIVE CONDUCTOR (see Form A.6) p
4.42.4 Equipment or parts for short-term or intermittent p
operation
4.42.5 Motors Brushless DC motor —
- stopped while fully energized (see Form A.1) p
- prevented from starting p
- one phase interrupted (multi-phase) N/A
4.4.2.6 Capacitors No such capacitors N/A
44.2.7 MAINS transformers Mains transformer is used in N/A
certificated PSU, no additional
tests considered necessary
4.42.7.2 Short circuit N/A
44.2.7.3 Overload N/A
4.4.28 Outputs (see Form A.1) P
44.2.9 Equipment for more than one supply Single supply N/A
4.4.2.10 Cooling (see Form A.26A) —
- air holes closed (see Form A.1) p
- fans stopped (see Form A.1) p
- coolant stopped N/A
- loss of cooling liquid N/A
4.4.2.11 Heating devices —
- timer overridden N/A
- temperature controller overridden (see Form A.1) P
4.4.2.12 Insulation between circuits and parts N/A
4.4.2.13 Interlocks P
4.4.2.14 Voltage selectors No voltage selector N/A
4.4.3 Duration of tests (see Form A.1) —
4.4.4 Conformity after application of fault conditions (see Forms A. 1, A.6 and A. 18) P
5 MARKING AND DOCUMENTATION p

5.1 Marking p
5.1.1 General p
TRF No. IEC61010 1L

IEC 61010-1
Required equipment markings —

- Visible from the exterior; or All labels located on the P
exterior of equipment
- Visible after removing cover or opening door N/A
- Visible after removal from a rack or panel N/A
Not put on parts which can be removed by an Not locate on such parts p
operator
Letter symbols (IEC 60027) used See copy of marking plate p
Graphic symbols of Table 1 used See copy of marking plate p
5.1.2 Identification Replaced by EN 61010-2-101 N/A
test report
Equipment is identified by: —
a) Manufacturer’s or supplier’s name or trademark N/A
b) Model number, name or other means N/A
Manufacturing location identified N/A
5.1.3 MAINS supply p
Equipment is marked as follows: —
a) Nature of supply: —
1) a.c. RATED MAINS frequency or range of
—
frequencies...................................................... 50/60 Hz
2) d.c. with symbol 1............................................... —
b) RATED supply voltage(s) or range............................. 220-240 V - —
c) Max. RATED power (W or VA) or input current.......... 60 VA —
The marked value not less than 90 % of the (see Form A.2) p
maximum value
If more than one voltage range: —
Separate values marked; or N/A
Values differ by less than 20 % N/A
d) OPERATOR-set for different RATED supply Single voltage —
voltages:
Indicates the equipment set voltage N/A
PoRTABLE EQUIPMENT indication is visible from N/A
the exterior
Changing the setting changes the indication N/A
e) Accessory MAINS socket-outlets accepting No such mains socket-outlets —
standard MAINS plugs are marked:
With the voltage if it is different from the MAINS —
supply voltage........................................................
For use only with specific equipment N/A
If not marked for specific equipment it is marked —
with:
TRF No. IEC61010 1L

EPiniftK Page 11 of 91 Report No. MEE202002154-01
IEC 61010-1
The maximum RATED current or power; or N/A

Symbol 14 with full details in the documentation N/A
5.1.4 Fuses T1AL250V p
OPERATOR replaceable fuse marking —
(see also 5.4.5).............................................................. :
5.1.5 TERMINALS, connections and operating devices Appropriately marked p
5.1.5.1 General p
Where necessary for safety, indication of purpose of Appropriately marked p
TERMINALS, connectors, controls and indicators
marked
If insufficient space, symbol 14 used N/A
Push-buttons and actuators of emergency stop No such devices —
devices and indicators:
- used only to indicate a warning of danger; or N/A
- the need for urgent action N/A
- coloured red N/A
- coded as specified in IEC 60073 N/A
Supplementary means of coding provided, if meaning —
of colour relates (see IEC 60073):
- to safety of persons; or N/A
- safety of the environment N/A
5.1.5.2 TERMINALS —
MAINS supply TERMINAL identified P
Other TERMINAL marking: —
a) FUNCTIONAL EARTH TERMINALS marked with No functional earth N/A
symbol 5
b) PROTECTIVE CONDUCTOR TERMINALS: —
Symbol 6 is placed close to or on the TERMINAL; P
or
Part of appliance inlet P
c) TERMINALS of circuits (symbol 7 used) No such terminals N/A
d) HAZARDOUS LIVE TERMINALS supplied from the No such terminals N/A
interior
Standard MAINS socket outlet used; or No such mains socket outlet N/A
RATINGS marked; or N/A
Symbol 14 used N/A
5.1.6 Switches and circuit-breakers The power switch is used only N/A
for function purpose, not for
disconnecting device. "I" and
"O” marked on the switch
If disconnecting device, off position clearly marked Not used as disconnecting N/A
device
TRF No. IEC61010 1L

EPinF'K Page 12 of 91 Report No. MEE202002154-01
IEC 61010-1
If push-button used as power supply switch: No push-button used —

- Symbol 9 and 15 used for on-position N/A
- Symbol 10 and 16 used for off-position N/A
- Pair of symbols 9, 15 and 10,16 close together N/A
5.1.7 Equipment protected by DOUBLE INSULATION or P
REINFORCED INSULATION
Protected throughout (symbol 11 used) N/A

Only partially protected (symbol 11 not used) P
5.1.8 Field-wiring TERMINAL boxes No field-wiring terminal boxes N/A
If TERMINAL or ENCLOSURE exceeds 60 °C: —

Cable temperature RATING marked............................... —
Marking visible before and during connection or N/A
beside TERMINAL
5.2 Warning markings P
Visible when ready for NORMAL USE p
Are near or on applicable parts p
Symbols and text correct dimensions and colour: —
a) Symbols min 2,75 mm and text 1,5 mm high and p
contrasting in colour with background
b) Symbols and text moulded, stamped or N/A
engraved in material min. 2,0 mm high and
0,5 mm depth or raised if not contrasting in N/A
colour
If necessary marked with symbol 14, or p
Additional symbols such as symbol 12, 13 or 17 Symbol 12 used p
used to indicate the nature of HAZARD
Statement to place equipment in a safe state before N/A
access by using a tool to HAZARDOUS parts is
permitted
5.3 Durability of markings P
The required markings remain clear and legible in (See Form A.3) P
NORMAL USE
5.4 Documentation p
5.4.1 General p
Equipment is accompanied by documentation for p
safety purposes for OPERATOR or RESPONSIBLE BODY
Safety documentation for service personnel p
authorized by the manufacturer
Documentation necessary for safe operation is p
provided in printed media or
in electronic media if available at any time N/A
Documentation includes: —
TRF No. IEC61010_1L

IEC 61010-1
a) Intended use p
b) Technical specification p
c) Name and address of manufacturer or supplier p
d) Information specified in 5.4.2 to 5.4.6 p
e) Information to mitigate residual RISK N/A
(see also subclause 17)
f) Accessories for safe operation of the equipment P
specified
g) Guidance provided to check correct function of p
the equipment, if incorrect reading may cause a
HAZARD from harmful or corrosive substances of
HAZARDoUS live parts
h) Instructions for lifting and carrying p

Warning statements and a clear explanation of —
warning symbols:
- provided in the documentation; or p
- information is marked on the equipment N/A
5.4.2 Equipment RATINGS P
Documentation includes: —
a) Supply voltage or voltage range................................ 220-240 V - —
Frequency or frequency range............................... 50/60 Hz —
Power or current rating........................................... 60 VA —
b) Description of all input and output connections in p
accordance to 6.6.1 a)
c) RATING of insulation of external circuits in N/A
accordance to 6.6.1 b)
d) Statement of the range of environmental —
conditions (refer to 1.4):
1) indoor or outdoor use, Indoor use P
2) altitude, Up to 2000 m P
3) temperature, 15 °C to 30 °C P
4) relative humidity, 40 % to 85 % p
5) MAINS supply voltage fluctuations, p
6) OVERVOLTAGE CATEGORY, II p
7) WET LOCATION, if applicable, Not used for wet location N/A
8) PoLLUTIoN DEGREE of the intended 2 P
environment
e) Degree of ingress protection (IEC 60529) N/A
f) If impact rating less than 5 J: —
IK code in accordance to IEC 62262 marked; or N/A
symbol 14 of Table 1 marked, with N/A
TRFNo. IEC61010 1L
IEC 61010-1
RATED energy level and test method stated N/A

5.4.3 Equipment installation Replaced by EN 61010-2-101 N/A
test report
Documentation includes instructions for: —
a) Assembly, location and mounting requirements N/A
b) Instructions for protective earthing N/A
c) Connections to supply N/A
d) PERMANENTLY CONNECTED EQUIPMENT: —
1) Supply wiring requirements N/A
2) If external switch or circuit-breaker, N/A
requirements and location recommendation
e) Ventilation requirements N/A
f) Safety characteristics for special external N/A
services (e. g. maximum and minimum
temperature, pressure, flow of air, cooling liquid)
g) Instructions relating to sound level N/A
5.4.4 Equipment operation Replaced by EN 61010-2-101 N/A
test report
Instructions for use include: —
a) Identification and description of operating N/A
controls
b) Positioning for disconnection N/A
c) Instructions for interconnection to accessories or N/A
other equipment
d) Specification of intermittent operation limits N/A
e) Explanation of symbols used N/A
f) Replacement of consumable materials N/A
g) Cleaning and decontamination N/A
h) Listing of any poisonous or injurious gases and N/A
quantities
i) RISK reduction procedures relating to flammable N/A
liquids (see 9.5 c)
j) RISK reduction procedures relating burn from N/A
surfaces permitted to exceed limits of 10.1
Additional precautions for IEC 60950 conforming N/A
equipment in regard to moistures and liquids
A statement about protection impairment if used in a N/A
manner not specified by the manufacturer
5.4.5 Equipment maintenance and service P
Instructions for RESPoNSIBLE BoDY include: —
Instructions sufficient in detail permitting safe —
maintenance and inspection and continued safety:
TRF No. IEC61010_1L

EPinKK Page 15 of 91 Report No. MEE202002154-01
IEC 61010-1
Instruction against the use of detachable MAINS p

supply cord with inadequate RATING
Specific battery type of user replaceable batteries No user replaceable batteries N/A
Any manufacturer specified parts P
RATING and characteristics of fuses P
Instructions include following subjects permitting safe —
servicing and continued safety:
a) Product specific RISKS may affect service P
personnel
b) Protective measures for these RISKS p
c) Verification of the safe state after repair p
5.4.6 Integration into systems or effects resulting from N/A
special conditions
Aspects described in documentation N/A
6 PROTECTION AGAINST ELECTRIC SHOCK P

6.1 General (see Forms A.14 and A.15) p
6.1.1 Requirements p
Protection against electric shock maintained in p
NORMAL CONDITION and SINGLE FAULT CONDITION
ACCESSIBLE parts not HAZARDOUS LIVE p
Voltage, current, charge or energy below the limits in —
NORMAL CONDITION and in SINGLE FAULT CONDITION
between:
ACCESSIBLE parts and earth p
two ACCESSIBLE parts on same piece of the equipment p
within a distance of 1,8 m
Conformity is checked by the determination of 6.2 p
and 6.3 followed by the tests of 6.4 to 6.11
6.1.2 Exceptions N/A
Following HAZARDOUS LIVE parts may be ACCESSIBLE No hazardous voltages are
to an OPERATOR: accessible to the operator
during normal use
a) parts of lamps and lamp sockets after lamp N/A
removal
b) parts to be replaced by OPERATOR only by the use N/A
of tool and warning marking
Those parts not HAZARDOUS LIVE 10 S after N/A
interruption of supply
Capacitance test if charge is received from internal N/A
capacitor
6.2 Determination of ACCESSIBLE parts (see Form A.4) P
6.2.1 General P
TRF No. IEC61010 1L

IEC 61010-1
Unless obviously determination of ACCESSIBLE parts P

as specified in 6.2.2 to 6.2.4
6.2.2 Examination p
- with jointed test finger (as specified B.2) p
- with rigid test finger (as specified B.1) and a force of p
10N
6.2.3 Openings above parts that are HAZARDOUS LIVE No opening above hazardous N/A
live parts
- test pin with length of 100 mm and 4 mm in N/A
diameter applied
6.2.4 Openings for pre-set controls No pre-set controls N/A
- test pin with length of 100 mm and 3 mm in N/A
diameter applied
6.3 Limit values for ACCESSIBLE parts p
6.3.1 Levels in NORMAL CONDITION (see Form A.5) p
a) Voltage limits less than 30 V r.m.s. and 42,4 V p
peak or 60 Vd.c.
for WET LOCATIONS voltage limits less than Not used in wet locations N/A
16 V r.m.s. and 22,6 V peak or 35 V d.c.
Voltages are not HAZARDOUS LIVE the levels of: —
b) Current less than 0,5 mA r.m.s. for sinusoidal, P
0,7 mA peak non-sinusoidal or mixed frequencies
or 2 mA d.c. when measured with measuring
circuit A. 1 or A.2 if less than 100 Hz
for WET LOCATIONS measuring circuit A.4 used Not used in wet locations N/A
70 mA r.m.s. when measured with circuit A.3 for N/A
higher frequencies
c) Levels of capacitive charge or energy less: —
1) 45 pC for voltages up to 15 kV peak or d.c. or N/A
line A of Figure 3
2) 350 mJ stored energy for voltages above N/A
15kV peak or d.c.
6.3.2 Levels in SINGLE FAULT CONDITION (see Form A.6) P
a) Voltage limits less than 50 V r.m.s. and p
70 V peak or 120 Vd.c.
for WET LOCATIONS voltage limits less than Not used in wet locations N/A
33 V r.m.s. and 46,7 V peak or 70 V d.c.
Voltages are not HAZARDOUS LIVE the levels of: —
b) Current less than 3,5 mA r.m.s. for sinusoidal, p
5 mA peak non-sinusoidal or mixed frequencies
or 15 mA d.c. when measured with measuring
circuit A.1 or A.2 if less than 100 Hz
for WET LOCATIONS measuring circuit A.4 used Not used in wet locations N/A
TRFNo. IEC61010 1L
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IEC 61010-1
500 mA r.m.s. when measured with circuit A.3 for N/A

higher frequencies
c) Levels of capacitive charge or energy less line B N/A
of Figure 3
6.4 Primary means of protection P
6.4.1 General P
ACCESSIBLE parts prevented from being HAZARDOUS —
LIVE by one or more of following means:
a) ENCLOSURES or PROTECTIVE BARRIERS (see 6.4.2) P

b) BASIC INSULATION (see 6.4.3) p
c) Impedance (see 6.4.4) No such protective means N/A
6.4.2 ENCLOSURES or PROTECTIVE BARRIERS (see Forms A. 15 and A. 16) p
- meet rigidity requirements of 8.1 p
- meet requirements for BASIC INSULATION, if p
protection is provided by insulation
- meet requirements of 6.7 for CREEPAGE and p
CLEARANCES between ACCESSIBLE parts and
HAZARDOUS live parts, if protection is provided by
limited access
6.4.3 BASIC INSULATION (see Forms A. 15 and A. 16) p
- meet CLEARANCE, CREEPAGE DISTANCE and solid p
insulation requirements of 6.7
6.4.4 Impedance N/A
Impedance used as primary means of protection —
meets all the following requirements:
a) limits current or voltage to level of 6.3.2 N/A
b) RATED for maximum WORKING VOLTAGE and the N/A
amount of power it will dissipate
c) CLEARANCE, CREEPAGE DISTANCE between N/A
terminations of the impedance meet requirements
of BASIC INSULATION Of 6.7
6.5 Additional means of protection in case of SINGLE P
FAULT CONDITION
6.5.1 General P
ACCESSIBLE parts are prevented from becoming
HAZARDOUS live by the primary means of protection
and supplemented by one of:
a) PROTECTIVE BONDING (see 6.5.2) p
b) SUPPLEMENTARY INSULATION (see 6.5.3) p
c) automatic disconnection of the supply (see 6.5.5) No such protective means N/A
d) current- or voltage-limiting device (see 6.5.6) No such protective means N/A
Alternatively one of the single means of protection is —
used:
TRF No. IEC61010 1L

IEC 61010-1
e) REINFORCED INSULATION (see 6.5.3) p

f) PROTECTIVE IMPEDANCE (see 6.5.4) N/A
6.5.2 PROTECTIVE BONDING (see Forms A.7, A.8, A.9, A.10 P
orA.11)
6.5.2.1 General p
ACCESSIBLE conductive parts, may become —
HAZARDOUS LIVE in SINGLE FAULT CONDITION:
Bonded to the PROTECTIVE CONDUCTOR TERMINAL; or p
Separated by conductive screen or barrier bonded to Not used such means N/A
PROTECTIVE CONDUCTOR TERMINAL
6.52.2 Integrity of PROTECTIVE BONDING —
a) PROTECTIVE BONDING consists of directly P
connected structural parts or discrete
conductors or both; and withstands thermal and
dynamic stresses
b) Soldered connections: No soldered connections —
Independently secured against loosening N/A
Not used for other purposes N/A
c) Screw connections are secured P
d) PROTECTIVE BONDING not interrupted; or p
except as removable part that carries MAINS N/A
SUPPLY input connection to the whole equipment
e) Any movable PROTECTIVE BONDING connection No such parts N/A

specifically designed, and meets 6.5.2.4
f) No external metal braid of cables used No such cables N/A
(not regarded as PROTECTIVE BONDING)
g) IF MAINS SUPPLY passes through: —
Means provided for passing protective conductor; N/A
Impedance meets 6.5.2.4 N/A
h) Protective conductors bare or insulated, P
if insulated, green/yellow
Exceptions: —
1) earthing braids; N/A
2) internal protective conductors etc.; N/A
Green/yellow not used for other purposes P
TERMINAL suitable for connection of a PROTECTIVE P
CONDUCTOR, and meets 6.5.2.3
6.52.3 PROTECTIVE CONDUCTOR TERMINAL Approved appliance inlet used —
a) Contact surfaces are metal P
b) Appliance inlet used P
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IEC 61010-1
c) For rewirable cords and PERMANENTLY No such case N/A

CONNECTED EQUIPMENT, PROTECTIVE CONDUCTOR
TERMINAL is Close to MAINS Supply TERMINALS
d) If no MAINS supply is required, any PROTECTIVE Mains supply is required —

CONDUCTOR TERMINAL:
Is near terminals of circuit for which protective N/A

earthing is necessary
External if other terminals external N/A
e) Equivalent current-carrying capacity to MAINS (see Form A.7) p
supply TERMINALS
f) If plug-in, makes first and breaks last p
g) If also used for other bonding purposes, Not used for other bonding —
PROTECTIVE CONDUCTOR: purposes
Applied first; N/A
Secured independently; N/A
Unlikely to be removed by servicing N/A
h) PROTECTIVE CONDUCTOR of measuring circuit: No measuring circuit —
1) Current RATING equivalent to measuring N/A
circuit TERMINAL;
2) PROTECTIVE BONDING: not interrupted by any N/A
switch or interrupting device
i) FUNCTIONAL EARTH TERMINALS allow independent N/A
connection
j) If a binding screw used for PROTECTIVE No binding screw used —
CONDUCTOR TERMINAL:
Suitable size for bond wire N/A

Not smaller than M 4 N/A
At least 3 turns of screw engaged N/A
Passes tightening torque test N/A
k) Contact pressure not capable being reduced by P
deformation of materials
65.2.4 Impedance of PROTECTIVE BONDING of plug-connected (see Form A.9) P
equipment
Impedance between PROTECTIVE CONDUCTOR
TERMINAL and each ACCESSIBLE part where
PROTECTIVE BONDING is specified, is:
- less than 0,1 Ohm; or P

- less than 0,2 Ohm if equipment is provided with Detachable cord used N/A
non-detachable cord
6.5.2.5 Impedance of PROTECTIVE BONDING of PERMANENTLY Not permanently connected N/A
CONNECTED EQUIPMENT equipment
6.5.2.6 Transformer PROTECTIVE BONDING screen No transformer protective N/A
bonding screen
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IEC 61010-1
Transformer provided with screen for PROTECTIVE —

BONDING:
screen bonding consists of directly connected N/A

structural parts or discrete conductors or both;
and withstands thermal and dynamic stresses
(see 6.5.2.2 a)
screen bonding with soldered connection (see —
65.2.2 b) is:
- Independently secured against loosening N/A
- Not used for other purposes N/A
6.5.3 SUPPLEMENTARY and REINFORCED INSULATION P
Meet CLEARANCE, CREEPAGE DISTANCE and Solid P
insulation requirements of 6.7
6.5.4 PROTECTIVE IMPEDANCE No such protective means N/A
Limits current or voltage to level of 6.3.1 in NORMAL N/A
and to level of 6.3.2 in SINGLE FAULT CONDITION
CLEARANCE, CREEPAGE DISTANCE between N/A
terminations of the impedance meet requirements of
DOUBLE or REINFORCED INSULATION Of 6.7
The PROTECTIVE IMPEDANCE consists of one or more of —
the following:
a) appropriate single component suitable for —
safety and reliability for protection, it is:
1) RATED twice the maximum WORKING VOLTAGE N/A
2) resistor RATED for twice the power dissipation N/A
for maximum WORKING VOLTAGE
b) combination of components N/A
Single electronic device not used as PROTECTIVE N/A
IMPEDANCE
6.5.5 Automatic disconnection of the supply No such protective means N/A
a) RATED to disconnect the load within time specified N/A
in Figure 2
b) RATED for the maximum load conditions of the N/A
equipment
6.5.6 Current- or voltage-limiting devices No such protective means N/A
Device complies with all of: —
a) RATED to limit the current or voltage to the level of N/A
6.3.2
b) RATED for the maximum WORKING VOLTAGE; and N/A
RATED for the maximum operational current if N/A
applicable
c) CLEARANCE, CREEPAGE DISTANCE between N/A
terminations of the impedance meet requirements
Of SUPPLEMENTARY INSULATION Of 6.7
TRFNo. IEC61010 1L
IEC 61010-1
6.6 Connections to external circuits P

6.6.1 General P
Connections do not cause ACCESSIBLE parts of the
following to become HAZARDOUS LIVE in NORMAL
CONDITION or SINGLE FAULT CONDITION:
- the external circuits p

- the equipment p
Protection achieved by separation of circuits; or p
short circuit of separation does not cause a HAZARD N/A
Instructions or markings for each terminal include: —
a) RATED conditions for TERMINAL P
b) Required RATING of external circuit insulation P
6.6.2 TERMINALS for external circuits N/A
TERMINALS which receive a charge from an internal N/A
capacitor are not HAZARDOUS LIVE after 10 s of
interrupting supply connection
6.6.3 Circuits with terminals which are HAZARDOUS LIVE N/A
These circuits are: —
Not connected to ACCESSIBLE conductive parts; or N/A
Connected to ACCESSIBLE conductive parts, but are N/A
not MAINS CIRCUITS and have one TERMINAL contact at
earth potential
No ACCESSIBLE conductive parts are HAZARDOUS LIVE N/A
6.6.4 Terminals for stranded conductors N/A
No RISK of accidental contact because: —
- Located or shielded N/A
- Self-evident or marked whether or not N/A
connected to ACCESSIBLE conductive parts
Complies as applicable: —
a) Manufacturer’s specified maximum length of N/A
removed insulation, or
b) 8 mm length of insulation removed N/A
6.7 Insulation requirements (see Form A. 14) P
6.7.1 The nature of insulation P
6.7.1.1 General P
Insulation between ACCESSIBLE parts or between P
separate circuits consist of CLEARANCES, CREEPAGE
DISTANCES and solid insulation if provided as
protection against a HAZARD
6.7.1.2 CLEARANCES p
Required CLEARANCES reflecting factors of 6.7.1.1 (see Forms A.14 and A.15) p
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IEC 61010-1
Equipment rated for operating altitude greater than Rated operating altitude: up to N/A
2000 m correction factor of Table 3 of 61010-1 2000 m
applied
6.7.1.3 CREEPAGE DISTANCES p
Required CREEPAGE DISTANCES reflecting factors of (see Forms A.14 and A.15) p
6.7.1.1 a) tod)
CTI material group reflected by requirements Material group lllb is assumed p
CTI test performed N/A
6.7.1.4 Solid insulation P
Required solid insulation reflecting factors of (see Forms A.14 and A.15) p
6.7.1.1 a) tod)
6.7.1.5 Requirements for insulation according to type of (see Forms A.14 and A.15) p
circuit
a) 6.7.2 MAINS circuits of OVERVOLTAGE CATEGORY II p
up to nominal supply voltage of 300 V
b) 6.7.3 secondary circuits separated from circuits Secondary circuits separated N/A
defined in a) by transformer from mains circuits by PSU
c) K.1 MAINS circuits of OVERVOLTAGE CATEGORY III No such category N/A
and IV or OVERVOLTAGE CATEGORY II over 300 V
d) K.2 secondary circuits separated from circuits No such category N/A
defined in c) by transformer
e) K.3 circuits having one or more of: —
1) maximum TRANSIENT OVERVOLTAGE is limited to N/A
known level below the level of MAINS CIRCUIT
2) maximum TRANSIENT OVERVOLTAGE above the N/A
level of MAINS CIRCUIT
3) WORKING VOLTAGE is the sum of more than one N/A
circuit or a mixed voltage
4) WORKING VOLTAGE includes recurring peak N/A
voltage, may include non-sinusoidal or
non-periodic waveform
5) WORKING VOLTAGE with a frequency above N/A
30 kHz
6.7.2 Insulation for MAINS CIRCUITS of OVERVOLTAGE P
CATEGORY II with a nominal supply voltage up to
300 V
6.7.2.1 CLEARANCES and CREEPAGE DISTANCES (see Forms A.14 and A.15) —
Values for MAINS CIRCUITS of Table 4 are met p
Coatings to achieve reduction to POLLUTION DEGREE 1 No such coatings N/A
comply with requirements of Annex H
6.7.2.2 Solid insulation P
6.7.2.2.1 General P
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IEC 61010-1
Withstands electrical and mechanical stresses in P

normal use and all RATED environmental conditions of
1.4
Equipment passed voltage tests of 6.8.3 with values (see Form A. 18) P
of Table 5
a) ENCLOSURE or PROTECTIVE BARRIER of Clause 8 p
b) moulded and potted parts requirements of Certified PSU N/A
67.2.2.2
c) inner layers of printed wiring boards requirements Certified PSU N/A
of 67.2.2.3
d) thin-film insulation requirements of 67.2.2.4 Certified PSU N/A
67.2.2.2 Moulded and potted parts —
Conductors between same two layers are separated Certified PSU N/A
by at least 0,4 mm after moulding is completed
67.2.2.3 Inner insulating layers of printed wiring boards Certified PSU —
Separated by at least 0,4 mm between same two N/A
layers
REINFORCED INSULATION have adequate electric —
strength; one of following methods used:
a) thickness of insulation is at least 0,4 mm N/A
b) insulation is assembled of minimum two separate N/A
layers, each RATED for test voltage of Table 5 for
BASIC INSULATION
c) insulation is assembled of minimum two separate N/A

layers, where the combination is rated for test
voltage of Table 5 for REINFORCED INSULATION
67.2.2.4 Thin-film insulation Certified PSU —
Conductors between same two layers are separated N/A
by applicable CLEARANCES and CREEPAGE DISTANCE of
67.2.1
strength; one of the following methods used:
a) thickness through the insulation at least 0,4 mm N/A
b) insulation is assembled of min. two separate N/A
BASIC INSULATION
c) insulation is assembled of min. three separate N/A

layers, where the combination of two layers
passed voltage tests of 6.8.3 with values of Table
5 for REINFORCED INSULATION
67.3 Insulation for secondary circuits derived from MAINS No hazardous voltage in N/A
CIRCUITS Of OVERVOLTAGE CATEGORY II up to 300 V secondary circuits, no
insulation considered
necessary
67.3.1 General N/A
TRF No. IEC61010 1L

IEC 61010-1
Secondary circuits where separation from MAINS —

CIRCUITS is achieved by a transformer providing:
- REINFORCED INSULATION N/A

- DOUBLE INSULATION N/A
- screen connected to the PROTECTIVE CONDUCTOR N/A
TERMINAL
6.73.2 CLEARANCES N/A

a) meet the values of Table 6 for BASIC INSULATION N/A
and SUPPLEMENTARY INSULATION; or
twice the values of Table 6 for REINFORCED N/A
INSULATION; or
b) pass the voltage tests of 6.8 with values of N/A

Table 6;
with following adjustments: —
1) values for reinforced insulation are 1,6 times the N/A
values for basic insulation
2) if operating altitude is greater than 2000 m values N/A
of CLEARANCES multiplied with factor of Table 3
3) minimum CLEARANCE is 0,2 mm for POLLUTION N/A
DEGREE 2 and 0,8 mm for POLLUTION DEGREE 3
6.7.3.3 CREEPAGE DISTANCES N/A

Based on WORKING VOLTAGE meets the values of N/A
Table 7 for BASIC and SUPPLEMENTARY INSULATION
Values for REINFORCED INSULATION are twice the N/A
values of BASIC INSULATION
Coatings to achieve reduction to POLLUTION DEGREE 1 N/A
comply with requirements of Annex H
6.7.3.4 Solid insulation N/A
6.7.3.4.1 General N/A
Withstands electrical and mechanical stresses in
normal use and all RATED environmental conditions of
1.4
a) Equipment passed voltage test of 6.8.3.1 for 5 s N/A
with VALUES of Table 6 for BASIC and
SUPPLEMENTARY INSULATION
values for REINFORCED INSULATION are 1,6 times N/A

the values of BASIC INSULATION
b) if WORKING VOLTAGE exceeds 300 V, equipment N/A
passed voltage test of 6.8.3.1 for 1 min with a test
voltage of 1,5 times working voltage for BASIC or
SUPPLEMENTARY INSULATION
value for REINFORCED INSULATION are twice the N/A

WORKING VOLTAGE
TRF No. IEC61010 1L

EPIATftK Page 25 of 91 Report No. MEE202002154-01
IEC 61010-1
1) ENCLOSURE or PROTECTIVE BARRIER of Clause 8 N/A

2) moulded and potted parts requirements of N/A
67.3.4.2
3) inner layers of printed wiring boards N/A
requirements of 67.3.4.3
4) thin-film insulation requirements of 67.3.4.4 N/A
6.7.34.2 Moulded and potted parts —
by applicable distances of Table 8
67.3.4.3 Inner insulation layers of printed wiring boards —
Separated by at least the applicable distances of N/A
Table 8 between same two layers
a) thickness at least applicable distance of Table 8 N/A
b) insulation is assembled of minimum two separate N/A
BASIC INSULATION
c) insulation is assembled of min. two separate N/A

layers, where the combination is RATED for 1,6
times the test voltage of Table 6
67.3.4.4 Thin-film insulation —
by applicable CLEARANCES and CREEPAGE DISTANCE
of 6 7.3.2 and 6.7.3.3
a) thickness at least applicable distance of Table 8 N/A
b) insulation is assembled of min. two separate N/A
BASIC INSULATION
c) insulation is assembled of min. three separate

layers, where the combination of two layers
passed voltage tests with 1,6 time values of
Table 6:
a.c. test of 6.8.3.1; or N/A
d.c. test of 6.8.3.2 for circuits stressed only by d.c. N/A
voltages
6.8 Procedure for voltage tests (see Forms A. 14 and A. 18) P
6.9 Constructional requirements for protection P
against electric shock
6.9.1 General p
If a failure could cause a HAZARD: —
TRF No. IEC61010 1L

IEC 61010-1
a) security of wiring connections All connections mechanically p

secured
b) screws securing removable covers No such screws N/A
c) accidental loosening P
d) CLEARANCES and CREEPAGE DISTANCES not P
reduced below the values of basic insulation by
loosening of parts or wires
6.9.2 Insulating materials p
Material not to be used for safety relevant insulation: —
a) easily damaged materials not used No such material used p
b) non-impregnated hygroscopic materials not used No such material used p
6.9.3 Colour coding p
Green-and-yellow insulation shall not be used except: —
a) protective earth conductors; p
b) PRoTECTIVE BONDING conductors; p
c) potential equalization conductors; No such conductors N/A
d) functional earth conductors No such conductors N/A
6.10 Connection to MAINS supply source and p
connections between parts of equipment
6.10.1 MAINS supply cords p
RATED for maximum equipment current (see 5.1.3 c) p
Cable complies with IEC 60227 or IEC 60245 N/A
Heat-resistant if likely to contact hot parts N/A
Temperature RATING (cord and inlet)............................. —
Green/yellow used only for connection to PRoTECTIVE P
CONDUCTOR TERMINALS
Detachable cords with IEC 60320 MAINS connectors: —

Conform to IEC 60799; or N/A
Have the current RATING of the MAINS connector p
6.10.2 Fitting of non-detachable MAINS supply cords Detachable mains supply cords N/A
used
6.10.2.1 Cord entry —
a) inlet or bushing with a smoothly rounded opening; N/A
or
b) insulated cord guard protruding >5 D (diameter) N/A
6.10.2.2 Cord anchorage —
Protective earth conductor is the last to take the strain N/A
a) cord is not clamped by direct pressure from a N/A
screw
b) knots are not used N/A
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EPimaK Page 27 of 91 Report No. MEE202002154-01
IEC 61010-1
c) cannot push the cord into the equipment to cause N/A

a HAZARD
d) no failure of cord insulation in anchorage with N/A
metal parts
e) not to be loosened without a tool N/A
f) cord replacement does not cause a HAZARD and N/A
method of strain relief is clear
Push-pull and or torque test N/A
6.10.3 Plugs and connectors P
MAINS supply plugs, connectors etc., conform with (see TABLE 1) P
relevant specifications
If equipment supplied at voltages below 6.3.2.a) or —
from a sole source:
Plugs of supply cords do not fit MAINS sockets above N/A
rated SUPPLY voltage
MAINS type plugs used only for connection to MAINS p
supply
Plug pins which receive a charge from an internal (see Form A.5) p
capacitor
Accessory MAINS socket outlets: No accessory mains socket —
outlets
a) marking if accepts a standard MAINS supply plug N/A
(see 5.1.3e)
b) input has a protective earth conductor if outlet N/A
has EARTH TERMINAL CONTACT
6.11 Disconnection from supply source P
6.11.1 Disconnects all current-carrying conductors p
6.11.2 Exceptions No such exceptions N/A
6.11.3 Requirements according to type of equipment p
6.11.3.1 PERMANENTLY CoNNECTED EQUIPMENT and No such equipment N/A
multi-phase equipment
Employs switch or circuit-breaker N/A
If switch or circuit-breaker is not part of the —
equipment, documentation requires:
a) switch or circuit-breaker to be included in building N/A
installation
b) suitable location easily reached N/A
c) marking as disconnecting for the equipment N/A
6.11.3.2 Single-phase cord-connected equipment p
Equipment is provided with one of the following: —
a) switch or circuit-breaker Switch is not used as N/A
disconnecting device
b) appliance coupler (disconnectable without tool) P
TRF No. IEC61010 1L

IEC 61010-1
c) separable plug (without locking device) Separable plug is not used as N/A
6.11.4 Disconnecting devices Appliance coupler is used as P
6.11.4.1 General p
Disconnecting device part of equipment p
Electrically close to the SUPPLY p
Power-consuming components not electrically p
located between the supply source and the
Except electromagnetic interference suppression p
circuits permitted to be located on the supply side of
the disconnecting device
6.11.4.2 Switches and circuit-breakers The switch is used only for N/A
functional purpose
When used as disconnection device: —
Circuit breaker meets the relevant requirements IEC No circuit breaker used N/A
60947-2 and is suitable for the application
Switch meets the relevant requirements IEC 60947-3 The switch is not used as N/A
and is suitable for the application disconnecting device
Marked to indicate function........................................... —
Not incorporated in MAINS cord P
Does not interrupt PROTECTIVE EARTH CONDUCTOR P
6.11.4.3 Appliance couplers and plugs P
Where an appliance coupler or separable plug is —
used as the disconnecting device (see 6.11.3.2):
Readily identifiable and easily reached by the P
operator
Single-phase portable equipment cord length not p
more than 3 m
PROTECTIVE EARTH CONDUCTOR connected first and p
disconnected last
7 PROTECTION AGAINST MECHANICAL HAZARDS P

7.1 General P
Equipment does not cause a mechanical HAZARD in P
NORMAL nor in SINGLE FAULT CONDITION
Conformity is checked by 7.2 to 7.7 P

7.2 Sharp edges No sharp edges P
Easily-touched parts are smooth and rounded P
Do not cause injury during NORMAL USE and P
Do not cause injury during SINGLE FAULT CONDITION P
TRFNo. IEC61010 1L
IEC 61010-1
7.3 Moving parts p

7.3.1 General p
HAZARDS from moving parts limited to a tolerable level N/A
with the conditions specified in 7.3.2 and 7.3.5
RISK assessment in accordance with 7.3.3 carried out P
7.3.2 Exceptions N/A
Access to HAZARDOUS moving parts permitted under —
following circumstances:
a) obviously intended to operate on parts or N/A
materials external of the equipment
inadvertent touching of moving parts minimized N/A
by equipment design (e.g. guards or handles)
b) If OPERATOR access is unavoidable outside
NORMAL USE following precautions have been
taken:
1) access requires TOOL N/A
2) statement about training in the instructions N/A
3) warning markings on covers prohibiting access N/A
by untrained OPERATORS
or symbol 14 with full details in documentation N/A
7.3.3 RISK assessment for mechanical HAZARDS to body The moving part (rotating p
parts plate) is considered
RISK is reduced to a tolerable level by protective Severity: S p
measures as specified in Table 12 Probability: E1
Possibility: P2
Minimum protective measures: —
A. Low level measures N/A
B. Moderate measures N/A
C. Stringent measures Interlock used P
7.3.4 Limitation of force and pressure N/A
Following levels are met in NORMAL and SINGLE FAULT —-
CONDITION:
Continuous contact pressure below 50 N / cm2 with N/A

force below 150 N
Temporary force below 250 N for an area at least of N/A
3 cm2 for a maximum duration of 0,75 s
7.3.5 Gap limitations between moving parts N/A
7.3.5.1 Access normally allowed —
If levels of 7.3.4 exceeded and a body part may be N/A
inserted minimum gap as specified in Table 13
assured in NORMAL and in SINGLE FAULT CONDITION
7.35.2 Access normally prevented —
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IEC 61010-1
Maximum gap as specified in Table 14 assured in N/A

NoRMAL and in SINGLE FAULT CoNDITIoN
7.4 Stability P
Equipment not secured to building structure is P
physical stable
Stability maintained after opening of drawers etc. by No drawers N/A
automatic means, or
warning marking requires the application of means N/A
Compliance checked by following tests as applicable: (see Form A.20A) —
a) 10° tilt test for other than handheld equipment p
b) multi-directional force test for equipment exceeds N/A
height of 1 m and mass of 25 kg
c) downward force test for floor-standing equipment N/A
d) overload test with 4 times maximum load for N/A
castor or support foot that supports greatest load,
or
e) castor or support foot that supports greatest load N/A
removed from equipment
7.5 Provisions for lifting and carrying P
7.5.1 General N/A
Equipment more than 18 kg.......................................... Not more than 18 kg N/A
Has means for lifting or carrying; or N/A
Directions are given in documentation N/A
7.5.2 Handles and grips N/A
Handles or grips withstand four times weight N/A
7.5.3 Lifting devices and supporting parts N/A
RATED for maximum load; or N/A
Tested with four times maximum static load N/A
7.6 Wall mounting Not for wall mounting N/A
Mounting brackets withstand four times weight N/A
One fastner removed and test repeated with two N/A
times weight
7.7 Expelled parts Rotating plate is considered P
Equipment contains or limits the energy P
Protection not removable without the aid of a tool N/A
8 RESISTANCE TO MECHANICAL STRESSES P

8.1 General P
Equipment does not cause a HAZARD when subjected p
to mechanical stresses in NoRMAL USE
Normal protection level is 5 J p
TRF No. IEC61010 1L

IEC 61010-1
Levels below 5 J but not less than 1 J are acceptable —

if all of the following criteria are met:
a) Lower level justified by RISK assessment of N/A
manufacturer
b) Equipment installed in its intended application is N/A
not easily touched
c) Only occasional access during NORMAL USE N/A
d) IK code in accordance to IEC 62262 marked or N/A
symbol 14 used with full information in the
documentation
for non-metallic ENCLOSURES rated below 2 °C N/A
ambient temperature value chosen for minimum
RATED temperature
impact energies between IK values, the IK code N/A

marked for nearest lower value
Conformity is checked by performing following tests: (see Form A. 16) —
1) Static test of 8.2.1 P
2) Impact test of 8.2.2 with 5 J except for HAND-HELD p
EQUIPMENT
if specified impact energy is not 5 J alternate N/A

method of IEC 62262 used
3) Drop test of 8.3.1 or 8.3.2 except for FIXED P
EQUIPMENT and equipment with mass over 100 kg
Equipment RATED with an impact rating of IK 08 that N/A

obviously meets the criteria
After the tests inspection with following results: —
- HAZARDOUS LIVE parts above the limits of 6.3.2 not P
ACCESSIBLE
- insulation pass the voltage tests of 6.8 (see Form A.30) P

i) No leaks of corrosive and harmful substances P
ii) ENCLOSURE shows no cracks resulting in a P
HAZARD
iii) CLEARANCES not less than their permitted values P

iv) Insulation of internal wiring remains undamaged P
v) PROTECTIVE BARRIERS not damaged or loosened P
vi) No moving parts exposed, except permitted by P
7.3
vii) No damage which could cause spread of fire P
8.2 ENCLOSURE rigidity test P
8.2.1 Static test (see Form A.21A) P
- 30 N with 12 mm rod applied to each part of P
ENCLOSURE
TRFNo. IEC61010 1L
IEC 61010-1
- in case of doubt test conducted at maximum RATED N/A

ambient temperature
8.2.2 Impact test (see Form A.21A) P
Impact applied to any part of ENCLOSURE causing a P
HAZARD if damaged
Impact energy level and corresponding IK code........... —
Non-metallic ENCLOSURES cooled to minimum RATED N/A
ambient temperature if below 2 °C
8.3 Drop test (see Form A.21B) P
8.3.1 Other than HAND-HELD and DIRECT-PLUG-IN EQUIPMENT P
Tests conducted with a drop height or angle of............ —
8.3.2 HAND-HELD and DIRECT-PLUG-IN EQUIPMENT No such equipment N/A
Non-metallic ENCLOSURES cooled to minimum RATED N/A
ambient temperature if below 2 °C
Drop test conducted with an height of 1 m N/A
9 PROTECTION AGAINST THE SPREAD OF FIRE p

9.1 General P
No spread of fire in NORMAL and SINGLE FAULT p
CONDITION
MAINS supplied equipment meets requirements of 9.6 p

additionally
Conformity is checked by minimum one or a (see Form A.22) —
combination of the following (see Figure 11):
a) SINGLE FAULT test of 4.4; or (see Form A. 1) p
b) Application of 9.2 (eliminating or reducing the Not used such means N/A
sources of ignition); or
c) Application of 9.3 (containment of fire within the P
equipment)
9.2 Eliminating or reducing the sources of ignition Not used such means N/A
within the equipment
a) 1) Limited-energy circuit (see 9.4); or N/A
2) BASIC INSULATION provided for parts of N/A
different potential; or
Bridging the insulation does not cause ignition N/A
b) Surface temperature of liquids and parts (see N/A
9.5)
c) No ignition in circuits designed to produce heat N/A
9.3 Containment of the fire within the equipment, P
should it occur
9.3.1 General P
TRF No. IEC61010_1L

EPIM&K Page 33 of 91 Report No. MEE202002154-01
IEC 61010-1
Spread of fire outside equipment reduced to a —

tolerable level if:
a) Energizing of the equipment is controlled by an N/A
oPERAToR held switch
b) ENCLoSURE is conform with constructional P

requirements of 9.3.2; and
Requirements of 9.5 are met N/A
9.3.2 Constructional requirements P
a) Connectors and insulating material have (see TABLE 1. A) P
flammability classification V-2 or better
b) Insulated wires and cables are flame (see TABLE 1.A) P
retardant (VW-1 or equivalent)
c) ENCLoSURE meets following requirements: (see Form A.22) —
1) Bottom and sides in arc of 5 ° (see Figure 13) to —
non-limited circuits (9.4) meets:
i) no openings; or P
ii) perforated as specified in Table 16; or N/A
iii) metal screen with a mesh; or N/A
iv) baffles as specified in Figure 12 N/A
2) Material of ENCLoSURE and any baffle or flame —
barrier is made of:
Metal (except magnesium); or P
Non-metallic materials have flammability (see TABLE 1. A) P
classification V-1 or better
3) ENCLoSURE and any baffle or flame barrier have P
adequate rigidity
9.4 Limited-energy circuit No such circuit N/A
a) Potential not more than 30 r.m.s. and 42,4 V N/A
peak, or 60 V d.c.
b) Current limited by one of following means: —
1) Inherently or by impedance (see Table 17); N/A
or
2) Overcurrent protective device (see Table N/A
18); or
3) A regulating network limits also in SINGLE N/A
FAULT CoNDITIoN (see Table 17)
c) Is separated by at least BASIC INSULATIoN N/A

Fuse or a nonadjustable electromechanical device is N/A
used
9.5 Requirements for equipment containing or using Equipment does not contain or N/A
flammable liquids use flammable liquids
Flammable liquids contained in or specified for use N/A
with equipment do not cause spread of fire
TRF No. IEC61010 1L

IEC 61010-1
RISK is reduced to a tolerable level: —

a) The temperature of surface or parts in contact N/A
with flammable liquids is 25 °C below fire point
b) The quantity of liquid is limited N/A
c) Flames are contained within the equipment N/A
Detailed instructions for RiSK-reduction provided N/A
9.6 Overcurrent protection Dual fuses are used between p
appliance inlet and PSU input
9.6.1 General p
MAINS supplied equipment protected p
BASIC INSULATION between MAINS parts of opposite p
polarity provided
Overcurrent protection devices not fitted in the Not fitted in the protective p
protective conductor conductor
Fuses or single-pole circuit-breakers not fitted in Single-phase equipment N/A
neutral (multi-phase equipment)
9.6.2 PERMANENTLY CONNECTED EQUIPMENT Not permanently connected N/A
equipment
Overcurrent protection device: —
Fitted within the equipment; or N/A
Specified in manufacturer's instructions N/A
9.6.3 Other equipment —
Protection within the equipment P
10 EQUIPMENT TEMPERATURE LIMITS AND RESISTANCE TO HEAT p

10.1 Surface temperature limits for protection against p
burns
Easily touched surfaces within the limits in NORMAL (see Form A.26A) —
and in SINGLE FAULT CONDITION:
- at an specified ambient temperature of 40 °C p
- for equipment rated above 40 °C ambient N/A
temperature limits not exceeded raised by the
difference to 40 °C
Heated surfaces necessary for functional reasons —
exceeding specified values:
- Are recognizable as such by appearance or N/A
function; or
- Are marked with symbol 13 N/A
- Guards are not removable without tool N/A

10.2 Temperatures of windings P
Limits not exceeded in: —
NORMAL CONDITION P
TRF No. IEC61010 1L

IEC 61010-1
SINGLE FAULT CONDITION (see Form A.1) p

10.3 Other temperature measurements p
Following measurements conducted if applicable: (see Form A.26A) —
a) Value of 60 °C of field-wiring terminal box not No field-wiring terminal box N/A
exceeded
b) Surface of flammable liquids and parts in contact No flammable liquids N/A
with this liquids
c) Surface of non-metallic ENCLoSURES P
d) Parts made of insulating material supporting P
parts connected to MAINS supply
e) Terminals carrying a current more than 0,5 A P
10.4 Conduct of temperature tests p
10.4.1 General p
Tests conducted under reference test conditions and (see Form A.26A) p
manufacturer’s instructions
Tests alternatively conducted at the least favourable
ambient temperature within the RATED ambient
temperature...................................................................
10.4.2 Temperature measurement of heating equipment p
Tests conducted in test corner p
10.4.3 Equipment intended for installation in a cabinet or wall Not intended for installation in a N/A
cabinet or wall
Equipment built in as specified in installation Not for built in N/A
instructions
10.5 Resistance to heat P
10.5.1 Integrity of CLEARANCE and CREEPAGE DISTANCES (see Form A. 16) p
10.5.2 Non-metallic ENCLOSURES (see Form A.27) p
Within 10 min after treatment: —
Equipment subjected to suitable stresses of 8.2 and p
8.3 complying with criteria of 8.1
10.5.3 Insulating material p
a) Parts supporting parts connected to MAINS p
supply
b) TERMINALS carrying a current more than 0,5 A p
Examination of material data; or p
in case of doubt: —
1) Ball pressure test; or (see Form A.28) p
2) Vicat softening test of ISO 306 N/A
11 PROTECTION AGAINST HAZARDS FROM FLUIDS AND SOLID FOREIGN p

OBJECTS
TRF No. IEC61010 1L

IEC 61010-1
11.1 General P
Protection to oPERAToRS and surrounding area P
provided by EQUIPMENT
All fluids specified by manufacturer considered P
11.2 Cleaning (see Form A.30) P
11.3 Spillage N/A
11.4 Overflow N/A
11.5 Battery electrolyte N/A
Battery electrolyte leakage presents no HAZARD Lithium battery is used on the N/A
display control board
11.6 Equipment RATED with a degree of ingress (see Form A.30) N/A
protection (IP code)
11.6.1 General N/A
Equipment marked with IP code................................... —
Conditions specified in the documentation N/A
11.6.2 Conditions for testing N/A
Equipment in clean and new condition, all parts in N/A
place and mounted as specified by manufacturer
Complete equipment tested, or N/A
representative parts tested N/A
HAND-HELD EQUIPMENT and PORTABLE EQUIPMENT N/A
placed in least favourable position of NoRMAL use
Other equipment positioned or installed as specified N/A
TERMINALS provided with protective cap or cover, are N/A
installed as specified by manufacturer
The equipment is operating (energized) during the —
treatment except:
a) If manufacturer specifies degrees of protection N/A
for non-operating (de-energized) equipment, or
b) Equipment is operating or non-operating during N/A
the treatment with does not affect the test results
11.6.3 Protection against solid foreign objects (including N/A
dust)
Applicable test of IEC 60529 for protection against N/A
solid foreign objects conducted
Additionally inspection of equipment resulted: —
a) No deposit on insulation parts that could lead to N/A
a HAZARD
b) No created accumulations that have the N/A
potential to cause spread of fire
11.6.4 Protection against water N/A
TRF No. IEC61010_1L

IEC 61010-1
Applicable test of IEC 60529 for protection against N/A

water conducted
If any water has entered, safety is not impaired, —
inspection of equipment resulted:
a) No deposit on insulation parts that could lead to N/A
a HAZARD
b) Water has not reached hazardous live parts or N/A
windings which are not designed to operate
when wet
c) No accumulations near the end of cable nor N/A
enter the cable where it could cause a HAZARD
d) No accumulations where it could lead to a N/A
HAZARD taking in consideration movement of the
equipment
11.7 Fluid pressure and leakage No such hazards N/A
11.7.1 Maximum pressure........................................................: —
Maximum pressure of any part does not exceed N/A
PRATED
11.7.2 Leakage and rupture at high pressure N/A

Fluid-containing parts checked by inspection or if a —
HAZARD could arise subjected to hydraulic test, if:
a) product of pressure and volume > 200 kPa • I; N/A

and
b) pressure > 50 kPa N/A
Safety evidence established by calculation in acc. to N/A
national authorities (e.g. Pressure Equipment
Directive 2014/68/EU)
Parts of refrigerating systems meets pressure-related N/A
requirements of EN 378-2 or IEC 60335-2-89 as
applicable
11.7.3 Leakage from low-pressure parts N/A
11.7.4 Overpressure safety device No overpressure safety device N/A
Does not operate in NoRMAL USE N/A
a) Connected as close as possible to parts N/A
intended to be protected
b) Easy access for inspection, maintenance and N/A
repair
c) Adjustment only with TooL N/A
d) No discharge towards person N/A
e) No HAZARD from deposit of discharged material N/A
f) Adequate discharge capacity N/A
No shut-off valve between overpressure safety N/A
device and protected parts
TRF No. IEC61010_1L

EPiniaK Page 38 of 91 Report No. MEE202002154-01
IEC 61010-1
12 PROTECTION AGAINST RADIATION, INCLUDING LASER SOURCES, AND P

AGAINST SONIC AND ULTRASONIC PRESSURE
12.1 General P
Equipment provides protection The safety of barcode scanner N/E
not evaluated in this report
12.2 Equipment producing ionizing radiation N/A
12.2.1 Ionizing radiation No ionizing radiation N/A
12.2.1.1 General N/A
Equipment meets the following requirements: —
a) if intended to emit radiation meets requirements N/A
of 12.2.1.2; or
tested, classified and marked in accordance to N/A
IEC 62598
b) if only emits stray radiation meets requirements of N/A
12.2.1.3
12.2.1.2 Equipment intended to emit radiation —
Effective dose rate of radiation measured.................... —
If dose rate exceeds 5 pSv/h marked with the —
following:
a) symbol 17 (ISO 361) N/A
b) abbreviations of the radionuclides............................ —

c) with maximum dose at 1 m; or.................................. —
with dose rate value between 1 pSv/h and —
5 pSv/h in m...........................................................
12.2.1.3 Equipment not intended to emit radiation —
Limit for unintended stray radiation of 1 pSv/h at any N/A
easily reached point kept..............................................
12.2.2 Accelerated electrons N/A
Compartments opened only by the use of a TooL N/A
12.3 Optical radiation N/E
No unintentional HAZARDoUS escape of optical The safety of barcode scanner
radiation as ultraviolet, visible or infrared radiation, not evaluated in this report
including light emitting diodes:
- Checked by inspection; and N/E
- Radiation sources assessed in acc. to the N/E
requirements of IEC 62471, except for sources
considered to be safe (Table 22) or conditionally
safe (Table 23).
- Lamp and lamp systems assessed to Risk Groups N/A
1,2, or 3 of IEC 62471 are labelled in acc. to IEC
62471-2
- If labelling impractical, lamp or lamp systems N/A
marked with symbol 14
TRF No. IEC61010 1L

EPinraK Page 39 of 91 Report No. MEE202002154-01
IEC 61010-1
- Protective measures, restrictions on use, and N/A

operating instructions that may be necessary are
provided, including the applicable conditions of use
of Table 23.
12.4 Microwave radiation N/A
Power density does not exceed 10 W/m2...................... N/A
12.5 Sonic and ultrasonic pressure P
12.5.1 Sound level (see Form A.35) P
No HAZARDoUS sound emission P
Maximum sound pressure level measured and No hazardous sound level p
calculated for maximum sound power level as
specified in ISO 3746 or ISO 9614-1
Instruction describes measures for protection No protective measures N/A
required
12.5.2 Ultrasonic pressure No ultrasonic pressure N/A
Equipment not intended to emit ultrasound does not N/A
exceed limit of 110 dB between 20 kHz and 100 kHz
Equipment intended to emit ultrasound: N/A
Outside useful beam does not exceed limit of 110 dB N/A
between 20 kHz and 100 kHz
If inside useful beam above values exceeded: —
Marked with Symbol 14 of Table 1 N/A
and following information in the documentation: —
a) dimensions of useful beam N/A
b) area where ultrasonic pressure exceed 110 dB N/A
c) maximum sound pressure inside beam area N/A
12.6 Laser sources No laser sources N/A
Equipment meets requirements of IEC 60825-1 N/A
13 PROTECTION AGAINST LIBERATED GASES AND SUBSTANCES, EXPLOSION N/A

AND IMPLOSION
13.1 Poisonous and injurious gases and substances No such hazards N/A
No hazardous substances liberated in NoRMAL N/A
CoNDITIoNand in SINGLE FAULT CoNDITIoN
If potentially-hazardous substances are liberated: No hazardous substances —
liberated
Operator is not directly exposed to a quantity of the N/A
substance that could cause harm
Requirements to discharge of hazardous substances N/A
during NoRMAL operation in accordance to
manufacturer’s instructions not considered as
liberation
Attached data/test reports demonstrate conformity N/A
TRF No. IEC61010 1L

IEC 61010-1
13.2 Explosion and implosion No such hazards N/A

13.2.1 Components No such components N/A
Components liable to explode: —
Pressure release device provided; or N/A
Apparatus incorporates operator protection (see also N/A
7.7)
Pressure release device: —
Discharge without danger N/A
Cannot be obstructed N/A
13.2.2 Batteries and battery charging Manganese dioxide lithium P
coin battery is used which is
not intended to be replaced by
the user
If explosion or fire HAZARD could occur: No such hazards —
Protection incorporated in the equipment; or N/A
Instructions specify batteries with built-in protection N/A
In case of wrong type of battery used: —
No HAZARD; or N/A
Warning by marking and within instructions N/A
Equipment with means to charge rechargeable The battery used is not
—
batteries: rechargeable
Warning against the charging of non-rechargeable No charging circuit incorporated N/A
batteries; and in such equipment
Type of rechargeable battery indicated; or N/A
Symbol 14 used N/A
Battery compartment design N/A
Single component failure N/A
Polarity reversal test Test performed although it is P
not intended to be replaced by
the operator. See Form A. 37
13.2.3 Implosion of cathode ray tubes No cathode ray tubes N/A
If maximum face dimensions >160 mm........................ —
Intrinsically protected and correctly mounted; or N/A
ENCLoSURE provides protection: N/A
If non-intrinsically protected: —
Screen not removable without TooL N/A
If glass screen, not in contact with surface of tube N/A
14 COMPONENTS AND SUBASSEMBLIES P

14.1 General P
TRF No IEC61010 1L
IEC 61010-1
Where safety is involved, components and (see TABLE 1.A) p

subassemblies meet relevant requirements
14.2 Motors p
14.2.1 Motor temperatures p
Does not present a HAZARD when stopped or (see Forms A.1) p
prevented from starting; or
Protected by over-temperature or thermal protection N/A
device conform with 14.3
14.2.2 Series excitation motors No such motors N/A
Connected direct to device, if overspeeding causes a N/A
HAZARD
14.3 Overtemperature protection devices p

Devices operating in a SINGLE FAULT CONDITION (see Form A.38) p
a) Reliable function is ensured p
b) RATED to interrupt maximum current and voltage p
c) Does not operate in NORMAL USE p
If self-resetting device used to prevent a HAZARD, p
protected part requires intervention before restarting
14.4 Fuse holders p
No access to HAZARDOUS LIVE parts p
14.5 MAINS voltage selecting devices No such devices N/A
Accidental change not possible N/A
14.6 MAINS transformers tested outside equipment Mains transformer is used in N/A
certificated PSU
14.7 Printed wiring boards P
Data shows conformity with V-1 of IEC 60695-11-10 (see TABLE 1.A) P
or better; or
Test shows conformity with V-1 of IEC 60695-11-10 N/A
or better
Not applicable for printed wiring boards with No limited-energy circuits N/A
limited-energy circuits (9.4)
14.8 Circuits used to limit TRANSIENT OVERVOLTAGES N/A
Test conducted between each pair of MAINS SUPPLY N/A
TERMINALS
No ignition or overheating of other materials: —

- no ignition N/A
- no heat to other parts above the self-ignition points N/A
Safely suppressing and properly functional after N/A
applied tests
15 PROTECTION BY INTERLOCKS P
TRFNo. IEC61010 1L
EPiniCK Page 42 of 91 Report No. MEE202002154-01
IEC 61010-1
15.1 General P
Interlocks are designed to remove a HAZARD See general product P
before OPERATOR exposed information
15.2 Prevention of reactivation p
15.3 Reliability p
Single fault unlikely to occur; or N/A
Cannot cause a HAZARD The hall sensor was cycled to p
switch till twice the maximum
number that likely to occur
during the expected life had
completed. The protection was
not impaired after the test
16 HAZARDS RESULTING FROM APPLICATION p

16.1 REASONABLY FORESEEABLE MISUSE p
No HAZARDS arising from settings not intended and p
not described in the instructions
Other cases of REASONABLY FORESEEABLE MISUSE p
addressed by RISK assessment
16.2 Ergonomic aspects p
Factors giving rise to a HAZARD the RISK assessment —
is reflecting those aspects:
a) limitation of body dimensions N/A
b) displays and indicators P
c) accessibility and conventions of controls p
d) arrangement of TERMINALS p
17 RISK ASSESSMENT P
RISK assessment conducted, if HAZARD might arise P
and not covered by Clauses 6 to 16
TOLERABLE RISK achieved by iterative documented —
process covering the following:
a) RISK analysis P
Identifies HAZARDS and estimates RISK P
b) RISK evaluation P
Plan to judge acceptability of resulting RISK level P
based on the estimated severity and likelihood of
a RISK
c) RISK reduction P
Initial RISK reduced by counter measures; P
Repeated RISK evaluation without new RISKS p
introduced
TRF No. IEC61010 1L

EPinKK Page 43 of 91 Report No. MEE202002154-01
IEC 61010-1
RISKS remaining after RISK assessment addressed in —

instructions to RESPONSIBLE BODY:
Information contained how to mitigate these RISKS N/A
Following principles in methods of RISK reduction —
applied by manufacturer in given order:
1) RISKS eliminated or reduced as far as possible P
2) Protective measures taken for RISKS that cannot P
be eliminated
3) User information about residual RISK due to any P
defect of the protective measures
Indication of particular training is required p
Specification of the need for personal protective p
equipment
Conformity checked by evaluation of the RISK p
assessment documentation
ANNEX F ROUTINE TESTS P

Manufacturer's declaration P
ANNEX H QUALIFICATION OF CONFORMAL COATINGS FOR PROTECTION AGAINST N/A

POLLUTION
H.1 General N/A
Conformal coatings meet the requirements of Clause N/A
H.2 and H.3.
H.2 Technical properties N/A
Technical properties of conformal coatings are —
suitable for the intended application. In particular:
a) Manufacturer indicate that it is a coating for N/A
PWBs;
b) RATEDoperating temperature include the N/A
temperature range of the indicated application;
c) CTI, insulation resistance and dielectric strength N/A
are suitable for the intended application;
d) Coating have adequate UV resistance, if it is N/A
exposed to sunlight;
e) Flammability RATING of the coating is at least the N/A
required flammability RATING of the applied PWB.
H.3 Qualification of coatings N/A
Coating complies with the conformity requirements. N/A
ANNEX K INSULATION REQUIREMENTS NOT COVERED N/A

BY CLAUSE 6.7
TRF No. IEC61010 1L

EPim^K Page 44 of 91 Report No. MEE202002154-01
IEC 61010-1
Clause Requirement — Test
Result — Remark Verdict
4.4 TABLE: Testing in SINGLE FAULT CoNDITIoN - Results Form A.1 P

Test Fault Fault description Td 4.4.3 How was test terminated Meets
subclause No (NoTE) Comments 4.4.4
44.2.3 1 Interruption of protective conductor 10 min No hazard, see Form A.6 P
4.4.25 2 Brushless DC motor stopped while full energized 50 min Tm»= 64.7’C, the touch screen shows “detect error", no hazard P
4.4.28 3 USB output short circuited — No hazard, system protection P
4.4.2.10a) 4 Air holes closed 1h No hazard, see Form A.26A P
4.4.2.10b) 5 Cooling fan stopped 1h No hazard, see Form A.26A P
44.2.11 6 Heating circuit energized continuously 4h Thermal protector operated (Model: BH-B2D, Operating P
(Temperature controller overridden) temperature: 60 ± 5 °C). No hazard
4.4.2 7 USB connector overload — Max. load current 1.8 A, Power 7.8 W. No hazard P
NOTE Td = Test duration in hh.mm:ss
Record dielectric strength test on Form A.18 and temperature tests on Forms A.26A and / or A.26B.
Record in the comments column for each test whether carried out during or after SINGLE FAULT CoNDITIoN.
Supplementary information:
TRF No. IEC61010_1L

EPinic'K Page 45 of 91 Report No. MEE202002154-01
IEC 61010-1
Clause Requirement — Test Result — Remark Verdict
5.1.3c) TABLE: MAINS supply Form A.2 p

Marked rating.......................... 220-240 V —
Phase...................................... Single —
Frequency............................... 50/60 Hz —
Current..................................... —A —
Power...................................... —w —
Power...................................... 60 VA —
Test Voltage Frequency Current Power Comments

No. M [Hz] [A] [W] [VA]
1 198 50 0.204 — 40.44 For reference only
3 220 50 0.196 — 43.21
4 220 60 0.195 — 42.88
5 240 50 0.185 — 44.57
6 240 60 0.184 — 44.27
NOTE - Measurements are only required for marked ratings. Initial inrush currents are not regarded.
The input power was measured at the pre-heating stage, when the equipment at its maximum power
consumption.
TRF No. IEC61010 1L

EPinrax Page 46 of 91 Report No. MEE202002154-01
IEC 61010-1
5.3 TABLE: Durability of markings Form A.3 P

Marking method (see NoTE) Agent
1) Adhesive label A Water
2) Ink printed B Isopropyl alcohol 70%
3) Laser marked C (specify agent)
4) Film-coated (plastic foil control panel) D (specify agent)
5) Imprinted on plastic (moulded in) E (specify agent)
NOTE - Where applicable include print method, label material, ink or paint type,
fixing method, adhesive and surface to which marking is fixed.
Marking location Marking method (see above)

Identification (5.1.2) 1). 2)
MAINS supply (5.1.3) 1). 2)
Fuses (5.1.4) 1). 2)
Terminals and operating devices (5.1.5.2) N/A
Switches and circuit breakers (5.1.6) N/A
Double/reinforced equipment (5.1.7) N/A
Field wiring Terminal boxes (5.1.8) N/A
Warning marking (5.2) 1). 2)
Battery charging (13.2.2) N/A
Method Test agent Remains legible Label loose Curled edges Comments
Verdict Verdict Verdict
1). 2) A,B P P P
TRFNo. IEC61010 1L
EPI MOK Page 47 of 91 Report No. MEE202002154-01
IEC 61010-1
6.2 TABLE: List of ACCESSIBLE parts Form A.4 p

6.1.2 Exceptions —
6.2 Determination of ACCESSIBLE parts —
Item Description Determination method Exception under 6.1.2
(NOTE 5) (NOTE 4)
1 R232-1 serial port V
2 R232-2 serial port V
3 USB connector V
4 LAN connector V
5 Appliance inlet V
6 Touch screen V
7 Plastic enclosure V, R, J
8 Bottom metal enclosure v, R, J
NOTE 1 - Test fingers and pins are to be applied without force unless a force is specified (see 6.2.2)
NOTE 2 - Special consideration should be given to inadequate insulation and high voltage parts (see 6.2)
NOTE 3 - Parts are considered to be ACCESSIBLE if they could be touched in the absence of any covering which is not considered
to provide suitable insulation (see 6.4).
NOTE 4 - Capacitance test may be required (see Form A.5).
NOTE 5 - The determination methods are:
V = visual; R = rigid test finger; J = jointed test finger; P3 = pin 3 mm diameter; P4 = pin 4 mm diameter.
TRF No. IEC61010 1L

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IEC 61010-1
Clause Requirement — Test
Result — Remark Verdict
6 TABLE: Values In NoRMAL CoNDITIoN Form A.5 P

6.1.2 Exceptions 11.2 Cleaning and decontamination —
6.3.1 Values in NoRMAL CoNDITIoN (see NoTE 1) 11.3 Spillage —
6.6.2 Terminals for external circuit 11.4 Overflow —
6.10.3 Plugs and connections —
Item Voltage Current Capacitance 10 S / 5 S test (NOTE) Comments
(see V V V Test mA mA mA
Form A.4) r.m.s. peak d.c circuit r.m.s peak d.c. pC mJ V PC mJ
A1/A2/A3
1 — — 0 — — — — — — — — — R232-1 serial port
2 — — 0 — — — — — — — — — R232-2 serial port
3 — — 5 — — — — — — — — — USB connector
4 — — 0 — — — — — — — — — LAN connector
5 — — — — — — — — — — — — Appliance inlet
6 — — 0 — — — — — — — — — Touch screen
7 0 — — — — — — — — — — — Plastic enclosure
8 0 — — — — — — — — — — — Bottom metal enclosure
NOTE - A 10 s test is specified in 6.1.2 a) b). A. 5 s test is specified in 6.10.3. The capacitance level versus voltage below the limits given from figure 3 of IEC 61010-1
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IEC 61010-1
Clause [Requirement —Test | Result — Remark | Verdict
TRF No. IEC61010_1L

IEC 61010-1
6.5.2.2 TABLE: Cross-sectional area of bonding conductors Form A.7 P

Conductor location CRoSS-SECTIoNAL AREA Verdict
[mm2]
From the earth pin of appliance inlet 1.3 P
to earthed metal enclosure
The protective bonding conductor rated 16 AWG
6.5.2.3 TABLE: Tightening torque test Form A.8 N/A

Conductor location Size of screw Tightening Verdict
torque
[Nm]
— — — —
TRFNo. IEC61010 1L
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IEC 61010-1
6.5.2.4 TABLE: BONDING impedance of plug-connected equipment Form A.9 p

ACCESSIBLE part under test Test Voltage Calculated resistance Verdict
current attained (Maximum 0,1 or 0,2 Q)
after 1 min
[A] M [mfi] (NOTE 1)
Earth pin of appliance inlet to 25 0.8 32 p

accessible metal enclosure that
protectively earthed
NOTE 1 - For none-detachable power cord the impedance between protective conductor plug pin of MAINS cord and each
ACCESSIBLE part shall not exceed 0,2 Ohm.
6.5.2.5 TABLE: BONDING impedance of PERMANENTLY CONNECTED EQUIPMENT Form A.10 N/A
ACCESSIBLE part under test Test Voltage attained after 1 Verdict
current min (maximum 10 V)
[A] M
— — — —
6.5.2.6 TABLE: Transformer PROTECIVE BONDING screen Form A.11 N/A

ACCESSIBLE part under test Test current Voltage attained Calculated resistance Verdict
(see NOTE) after 1 min (maximum 0,1 Q)
(maximum 10 V)
[A] M [O]
— — — — —
NOTE - Test current must be twice the value of the overcurrent protection means of the winding. Test is specified in 6.5.2.6 a) or b).
TRF No. IEC61010 1L

EPIOTOK Page 52 of 91 Report No. MEE202002154-01
IEC 61010-1
Clause I Requirement — Test I Result — Remark I Verdict
6.5.4 | TABLE: PRoTECTIVE IMPEDANCE Form A.121 N/A

A single component
Component Location Measured Calculated Rated Verdict Comments
Working Current Power Working Power
voltage dissipation voltage dissipation
M [A] [W] M [W]
— — — — — — — — —
A combination of components
Component Location Comments
— — —
NOTE - A PROTECTIVE IMPEDANCE shall not be a single electronic device that employs electron conduction in a vacuum, gas or semiconductor
TRF No. IEC61010_1L

IEC 61010-1
EPlfiTSK Page 53 of 91 Report No MEE202002154-01
Clause | Requirement — Test

| Result — Remark | Verdict
6.5.6 | TABLE: Current- or voltage-limiting device Form A.131 N/A

Component Location Measured Rated Verdict Comments
Working Current Working Current
voltage voltage
(VJ [A] [A]
- — — — — — — —
TRF No. IEC61010_1L

IEC 61010-1
6.7 TABLE: Insulation requirements - Block diagram of system Form A.14
L
220-240 Vac
GND
Pollution degree.........: 2 Overvoltage category................II

Area Location Insulation WORKING VOLTAGE CLEARANCE CREEPAGE DISTANCE Test Comments
type (NOTE 3) (NOTE 3) voltage (NOTE 3)
(NOTE 1)
RMS Peak Freq. [mm] PWB CTI Other CTI (NOTE 2)
[V] M [kHz] [mm] [mm] [V
r.m.s.]
A Between L Bl 240 340 0.05 1.5 3.0 lllb 1500
and N
■ ■
before fuse
B Mains Bl 240 340 0.05 1.5 3.0 lllb 1500
circuits to
earthed
metal
enclosure
c Across the Bl 240 340 0.05 1.5 — — 3.0 lllb 1500
fuse
D Mains DI/RI 240 340 0.05 3.0 6.0 lllb 3000
circuits to
plastic
enclosure
E Between DI/RI 240 340 0.05 3.0 6.0 lllb 6.0 lllb 3000
Pri. circuits
and Sec.
circuits of
PSU
F Mains DI/RI 240 340 0.05 3.0 6.0 lllb 6.0 lllb 3000
circuits to
TRFNo. IEC61010 1L
EPIOTSK Page 55 of 91 Report No. MEE202002154-01
IEC 61010-1
6.7 TABLE: Insulation requirements - Block diagram of system - Form A.14

non-
hazardous
voltage
secondary
circuits
NOTE 1 - Type of insulation: NOTE 2 - Types of voltage NOTE 3 - OVERVOLTAGE CATEGORIES
Bl = BASIC INSULATION Peak impulse test voltage (pulse) or POLLUTION DEGREES which differ
DI = DOUBLE INSULATION r.m.s. should be shown under
"Comments" PI = PROTECTIVE IMPEDANCE d.c.
Rl = Reinforced INSULATION peak
SI = Supplementary INSULATION
see also Form A. 15 for further details
Supplementary Information:
TRF No. IEC61010_1L


EPIOTCrK
IEC 61010-1
Clause [Requirement — Test [Result—Remark | VerdicT
6.7 TABLE: Insulation requirements - CLEARANCES and CREEPAGES Form A.15 P

6.2.2 Examination 6.5.4 Protective impedance —
6.4.2 ENCLOSURES and protective barriers 6.5.6 Current- or voltage-limiting device —
6.4.4 Impedance 9.6.1 BASIC INSULATION between opposite polarity —
Area Location Insulation WORKING VOLTAGE CLEARANCE CREEPAGE DISTANCE CTI Verdict Comments
type (NOTE 2)
(See Form A. 14) (NOTE 1) RMS Peak Frequency Required Measured Required Measured
M M [kHz] [mm] [mm] [mm] [mm]
A Between L and N before Bl 240 340 0.05 1.5 3.8 3.0 4.1 lllb P
fuse
B Mains circuits to earthed Bl 240 340 0.05 1.5 4.2 3.0 4.2 lllb P
metal enclosure
C Across the fuse Bl 240 340 0.05 1.5 >5.5 3.0 >5.5 lllb P
D Mains circuits to plastic DI/RI 240 340 0.05 3.0 >3.9 6.0 >7.8 lllb P
enclosure
E Between Pri. circuits and DI/RI 240 340 0.05 3.0 — 6.0 — lllb P Separately approved unit
Sec. circuits of PSU D
F Mains circuits to non- DI/RI 240 340 0.05 3.0 >3.9 6.0 >7.8 lllb P
hazardous voltage
secondary circuits
NOTE 1 - refer to Form A. 14 for type of insulation shown in the insulation diagram NOTE 2 - to be used for definition of required insulation (see Form A. 14)
Input supply voltage........ : 220-240 | V 150/60 |HZ

11
The PSU was approved according to EN 60601-1:2006+A11+ A1+A12, DI/RI provided between input and output, the insulation of PSU considered comply with
the requirements of EN 61010-1(third edition), no further measurement considered necessary.
TRF No. IEC61010_1L

EPIfiT&K Page 57 of 91 Report No. MEE202002154-01
IEC 61010-1
Clause | Requirement — Test | Result — Remark | Verdict
6.7 TABLE: Insulation requirements - CLEARANCES and Form A.16 P

CREEPAGES
6.4.2 ENCLOSURES Or PROTECTIVE BARRIERS 9.6.1 Overcun-ent protection basic insulation between MAINS parts —
8 Mechanical resistance to shock and impact 10.5.1 Integrity of CLEARANCES and CREEPAGE DISTANCES —
Area Location Insulation Mechanical tests (NOTE) Test at max. Measured after test Verdict Comments
type (if required)
(See Form A. 14) Applied Rigidity Drop RATED CLEARANCE CREEPAGE
force (8.2) (8.3) ambient DISTANCE
[NJ Static Impact Normal Hand-held/ (10.5.1) [mm] [mm]

(8.2.1) (8.2.2) (8.3.1) Plug-in
A Between L and N Bl 30 30 N 5J 100 N/A 40’C 3.8 4.1 P
before fuse mm
B Mains circuits to Bl 30 30 N 5J 100 N/A 40 °C 4.2 4.2 P
earthed metal mm
enclosure
C Across the fuse Bl 30 30 N 5J 100 N/A 40 *C P
>5.5 >5.5
mm
D Mains circuits to DI/RI 30 30 N 5J 100 N/A 40 °C P
>3.9 >7.8
plastic enclosure mm
E Between Pri. DI/RI 30 30 N 5J 100 N/A 40 °C — — P Separately approved unit1)
circuits and Sec. mm
circuits of PSU
F Mains circuits to DI/RI 30 30 N 5J 100 N/A 40 °C P
>3.9 >7.8
non-hazardous mm
voltage secondary
circuits
NOTE - Refer to Form A. 18 for dielectric strength tests following the above tests.
1)
The PSU was approved according to EN 60601-1.2006+A11 + A1+A12, DI/RI provided between input and output, the insulation of PSU considered comply with
the requirements of EN 61010-1 (third edition), no further measurement considered necessary.
TRF No. IEC61010_1L

IEC 61010-1
Clause Requirement-Test Result — Remark Verdict
67.2.2.2 TABLE: Reliability of potted components Form A.17 (optional) N/A

14.1 b) Components and subassemblies N/A
Temperature Cycling Test
Manufacturer...................................................
Type.................................................................
Construction.....................................................
Potting compound............................................
CREEPAGE DISTANCES measured......................
CLEARANCES measured....................................
Thickness through insulation...........................
Adhesive test Pass/Fail...................................
Test temperature T °C.....................................
Cycles at U= AC 500 V Leakage current (at AC 500 V)
mA
Number of cycles Date 68 h / 1h/ 2h/ 1 h/
125 °C 25 °C 0°C 25 °C
1. Cycle from to
2. Cycle from to
3. Cycle from to
4. Cycle from to
5. Cycle from to
6. Cycle from to
7. Cycle from to
8. Cycle from to
9. Cycle from to
10. Cycle from to
After Cycling Test:
Humidity conditioning 48 h
Requirements for dielectric strength (s. insulation diagram) Test voltage V r.m.s. Verdict
Basic insulation V r.m.s.
Supplementary insulation V r.m.s.
Reinforced insulation V r.m.s.
NOTE - to be used for evaluation of components containing insulation through solid insulation, when the component standard require
thermal cycling test. Ref Clause 14.1 and Figure 15, option b)
TRF No. IEC61010_1L

IEC 61010-1
6.8 TABLE: Dielectric strength tests Form A.18 p

4.4.4.1 b) Conformity after application of SINGLE FAULT CoNDITIoNS' p
6.4 Primary means of protection2 p
6.6 Connections to external circuits p
6.7 Insulation requirements2 (see Annex K) N/A
6.10.2 Fitting of non-detachable MAINS supply cords1 N/A
9.2 a) 2) Eliminating or reducing the sources of ignition within the equipment N/A
9.4 c) Limited-energy circuit N/A
9.6.1 Overcurrent protection basic insulation between MAINS - parts P
Test site altitude......................................................................... 20 m —
Test voltage correction factor (see table 10)............................... N/A —
Location or Clause Humidity Working Test Comments Verdict
references from or voltage voltage (NOTE)
Forms A.1 and sub-clause
A.14 Yes/No [r.m.s./d.c.] [r.m.s./peak/d.c.]
A All No 240 V r.m.s. 1500 V r.m.s P

B All No 240 V r.m.s 1500 V r.m.s P
C All Yes 240 V r.m.s 1500 V r.m.s P
D All Yes 240 V r.m.s 3000 V r.m.s P
E All Yes 240 V r.m.s 3000 V r.m.s P
F All Yes 240 V r.m.s 3000 V r.m.s P
1Record the fault, test or treatment applied before the dielectric strength test.2 Humidity preconditioning required.
NOTE: Test duration may be recorded.
TRFNo. IEC61010 1L
IEC 61010-1
6.10.2 TABLE: Cord anchorage Form A.19 N/A

Location Mass Pull Verdict Torque Verdict Comment
[kg] [N] [Nm]
— — — — — — —
Dielectric strength test for 1 min. (6.8.3.1)................ V r.m.s.
TRF No. IEC61010 1L

IEC 61010-1
Clause I Requirement — Test

7. TABLE: Protection against mechanical HAZARDS Form A.20 N/A

7.3.4 Limitation of force and pressure —
7.3.5 Gap limitations between moving parts —
Part / Location Clause 7.3.4 Clause 7.3.5.1 Clause 7.3.5.2 Verdict Comments
Continuous Temporary Minimum gaps [mm] Maximum gaps [mm]
Contact pressure max. 250 N / Torso Head Leg Foot Toes Arm Hand Finger Head Foot Finger
max. 50 N /cm2 3 cm2 @ 500 300 180 120 50 120 100 25 120 35 4
@ max. 150 N max. 0,75 s
- — — — — — — — — — — — — — — —
TRF No. IEC61010.1L

EPIAK'K Page 62 of 91 Report No. MEE202002154-01
IEC 61010-1
Clause Requirement-Test Result - Remark Verdict
7.4 TABLE: Stability Form A.20A P

Equipment height / mass.......................................... 180 mm 3 kg —
Equipment (Containers) loaded............................... [no] —
Castors at unfavourable position.............................. [no] —
Doors, drawers and movable arms closed............... [no] —
Doors and drawers at unfavourable position........... [no] —
Location Tilt angle Applied force Comments Verdict
10° 250 N 20% 800 N 4 times
[N] load [N]
Front side 10° — — — P
Left side 10° — — — P
Rear side 10° — — — P
Right side 10° — — — p
Top side — — — — —
Working surface — — — — —
Ledge — — — — —
Castor / support foot — —
Castor / support foot —
removed
Desk-top equipment
7.6 TABLE: Wall mounting Form A.20B N/A

Equipment weight..................................................... kg —
Equipment mounted as specified by manufacturer..: [yes / no] —
Equipment mounted at plasterboard (drywall)......... [yes / no] —
More than one fastener used................................... [yes / no] —
Test maintained (after 5 s to 10 s to full load).......... 1 min —
Location Applied weight Comments Verdict
4 times 2 times
weight [kg] weight [kg]
Mounting brackets — — — —
Not for wall mounting
TRFNo. IEC61010 1L
IEC 61010-1
Clause Requirement - Test Result - Remark Verdict
8.2 TABLE: ENCLoSURE rigidity test Form A.21A p

8.2.1 Static test P
Material of enclosure................................................ Metal and non-metallic —
Preparation for the test: Operated until steady-state
and disconnected from the
supply mains before the test
Operated at ambient temperature............................ 40 °C 2h —
Location Comments Verdict
1) Plastic enclosure Clearances were not less than p
their permitted values.
Enclosure showed no cracks
which could cause a hazard
2) Metal enclosure Clearances were not less than p
8.2.2 TABLE: Impact test p

Material of enclosure................................................ Metal and non-metallic —
Corresponding IK-code............................................ — —
Preparation for the test: With the equipment held firmly —
against a rigid support
Cooled to (temperature)........................................... — °C —
1)Top Enclosure showed no cracks. P
Protective barrier of the
moving part has not been
damaged. No moving part was
exposed. After the test, the
equipment could work
normally, and the interlock
system was still effective
2) Side left / right Clearances were not less than P
3) Bottom Clearances were not less than P
TRF No. IEC61010—1L

EPiniCK Page 64 of 91 Report No. MEE202002154-01
IEC 61010-1
Clause Requirement-Test Result - Remark Verdict
8.3 TABLE: Drop test Form A.21 B P

8.3.1 Other equipment N/A
Location Raised up to Comments —
[mm] 30°
1) Front side 100 Clearances were not less than P
2) Rear side 100 Clearances were not less than p
3) Left side 30° Clearances were not less than p
4) Right side 30° Clearances were not less than p
Mass of equipment is 3 kg.
8.3.2 HAND-HELD EQUIPMENT and DIRECT PLUG-IN EQUIPMENT N/A

Material of enclosure............................................... Metal / non-metallic —
Preparation for the test: —
Cooled to (temperature).......................................... °C —
1) Side — —
2) Edge — —
3) Corner — —
TRFNo. IEC61010 1L
EPIfiT^K Page 65 of 91 Report No. MEE202002154-01
IEC 61010-1
Clause | Requirement — Test
9 TABLE: Protection against the spread of fire Form A.22 P

Item Source of HAZARD or area of the equipment Protection Protection details Verdict
considered (circuit, component, liquid etc.) Method
(9.1 a, bore)
1 All primary and secondary circuits 9.1a, 9.1c Fault condition tests performed. P
Metal fire enclosure provided.
TRF No. IEC61010_1L

IEC 61010-1
9.3.2 TABLE: Constructional requirements Form A.23 N/A

14.7 Printed wiring boards N/A
Material tested............................................................ —
Generic name............................................................. —
Material manufacturer................................................ —
Type............................................................................ —
Colour......................................................................... : —
Conditioning details.................................................... —
Sample
1 2 3 4 5 6
Thickness of specimen mm
Duration of flaming after first Application s
Duration of flaming plus glowing s
After second application
Specimen burns to holding clamp Yes/No
Cotton ignited Yes/No
Sample result Pass/Fail
TRF No. IEC61010 1L

EPimfiK Page 67 of 91 Report No. MEE202002154-01
IEC 61010-1
Clause | Requirement — Test~ Result — Remark Verdict
TRFNo. IEC61010_1L
EPIfiT&K Page 68 of 91 Report No. MEE202002154-01
IEC 61010-1
Clause | Requirement — Test | Result — Remark
| Verdict
TRF No. IEC61010_1L

IEC 61010-1
10. TABLE: Temperature Measurements Form A.26A p

10.1 Surface temperature limits - NORMAL CONDITION and / or SINGLE FAULT CONDITION p
10.2 Temperature of windings - NORMAL CONDITION and / or SINGLE FAULT CONDITION p
Operating conditions: Normal operation
Frequency...............: 50 Hz Test room ambient temperature (ta)... 17.0 °C

Voltage.................... 198 V Test duration....................................... 1h 0 min
Part / Location tm tc tmax Verdict Comments
[°C] [°C] [°C]
Mains plug 17.3 40.3 70 P Component rated
Supply cord 17.5 40.5 70 p Component rated
Mains connector 19.8 42.8 70 p Component rated
Power switch 20.2 43.2 70 p Table 19
Internal wire 26.4 49.4 80 p Component rated
220 V terminal on MCU board 19.6 42.6 100 p Table 19
PSU (ambient temperature) 41.8 64.8 70 p Component rated
MCU board 43.9 66.9 130 p Component rated
Motor 31.4 54.4 130 p Class of insulation. Class B
Touch screen 34.3 57.3 70 p Table 19
Heating module surface 41.2 64.2 85 p Table 19
Metal enclosure 19.2 42.2 65 p Table 19
Plastic enclosure 22.8 45.8 85 p Table 19
NOTE 1 - tn = measured temperature
tc = tm corrected (fm-f.+ 40 °C or max. RATED ambient)
tmax = maximum permitted temperature
NOTE 2 - see also 14.1 with reference to component operating conditions
NOTE 3 - Record values for NORMAL CONDITION and / or SINGLE FAULT CONDITION in this Form use additional form if necessary
NOTE 4 - see Form A.26B for details of winding temperature measurements
TRFNo. IEC61010 1L
cpiniaK Page 70 of 91 Report No. MEE202002154-01
IEC 61010-1
10. TABLE: Temperature Measurements Form A.26A P

Frequency............... 60 Hz Test room ambient temperature (ta)... 17.5 °C

Part / Location tm tc tmax Verdict Comments
[°C] [°C] [°C]
Mains plug 18.0 40.5 70 p Component rated
Supply cord 17.9 40.4 70 p Component rated
Mains connector 20.6 43.1 70 p Component rated
Power switch 20.5 43.0 70 p Table 19
Motor 30.6 53.1 130 p Class of insulation: Class B
NOTE 1 - tm » measured temperature
tc = tm corrected (fm-ta+ 40 °C or max. RATED ambient)
hnax = maximum permitted temperature
TRFNo. IEC61010 1L
IEC 61010-1

10.1 Surface temperature limits - NORMAL CONDITION and / or SINGLE FAULT CONDITION P
10.2 Temperature of windings - NORMAL CONDITION and / or SINGLE FAULT CONDITION P

Part / Location tm tc fmax Verdict Comments
[°C] [°C] [°C]
Supply cord 17.5 40.5 70 P Component rated
Mains connector 20.1 43.1 70 P Component rated
Power switch 20.1 43.1 70 P Table 19
NOTE 1 - tm = measured temperature
tc = tmcorrected (tm-fa+ 40 °C or max. RATED ambient)
tnai = maximum permitted temperature
TRF No. IEC61010 1L

IEC 61010-1

Frequency.............. 60 Hz Test room ambient temperature (ta)... 18.0 °C

[°C] [°C] [°C]
Supply cord 18.3 40.3 70 P Component rated
Mains connector 20.4 42.4 70 P Component rated
Power switch 20.2 42.2 70 P Table 19
Internal wire 26.6 48.6 80 P Component rated
220 V terminal on MCU board 20.5 42.5 100 P Table 19
NOTE 1 -tm = measured temperature
tc = corrected (fm-fa+ 40 °C or max. RATED ambient)
taax = maximum permitted temperature
TRFNo. IEC61010 1L
EPiniax Page 73 of 91 Report No. MEE202002154-01
IEC 61010-1

Operating conditions: Single fault condition: Ventilation blocked

Voltage....................: 264 V Test duration....................................... : 1h 01 min
[°C] [°C] [°C]
Mains plug 17.8 40.8 105 P
Supply cord 17.5 40.5 105 P
Mains connector 20.1 43.1 105 p
Power switch 20.1 43.1 105 p
Internal wire 26.3 49.3 105 p
220 V terminal on MCU board 20.1 43.1 105 p
PSU (ambient temperature) 45.2 68.2 105 p
Touch screen 34.0 57.0 105 p
Heating module surface 41.8 64.8 105 p
Metal enclosure 22.3 45.3 105 p
Plastic enclosure 21.7 44.7 105 p
NOTE 1 - tm = measured temperature
tc = tm corrected 40 °C or max. RATED ambient)
fmax = maximum permitted temperature
TRF No. IEC61010_1L

IEC 61010-1

Operating conditions: Single fault condition: Cooling Fan stopped
Frequency.............. 60 Hz Test room ambient temperature (ta)...: 17.0 °C

Part / Location fm tc fmax Verdict Comments
[°C] [°C] [°C]
Mains plug 17.8 40.8 105 P
Supply cord 17.5 40.5 105 p
Mains connector 20.1 43.1 105 p
Power switch 20.1 43.1 105 p
Internal wire 26.3 49.3 105 p
220 V terminal on MCU board 21.6 44.6 105 p
PSU (ambient temperature) 45.2 68.2 105 p
Touch screen 34.0 57.0 105 p
Heating module surface 41.8 64.8 105 p
Metal enclosure 22.3 45.3 105 p
Plastic enclosure 21.7 44.7 105 p
NOTE 1 - tn = measured temperature
tc = corrected (tm-ta+ 40 °C or max. RATED ambient)
tnax = maximum permitted temperature
TRF No. IEC61010 1L

EPI HIC K Page 75 of 91 Report No. MEE202002154-01
IEC 61010-1
10.2 TABLE: Temperature of windings Form A.26B N/A

Resistance method Temperature Measurements
44.2.7 MAINS transformers N/A
14.2.1 Motor temperatures N/A
Operating conditions..:
Frequency................. Hz Test room ambient temperature (ta1/ta2).: / °C (initial 1 final)

Voltage...................... V Test duration............................................. h min
Part / Designation Rcold Current tr tc tmax Verdict Comments
ZD
D§
B
[fi] [A] [K] [°C] [°C]

— — — — — — — — —
NOTE 1- /?«>« = initial resistance = final resistance
tr = temperature rise tc = tr corrected &= t, + [40 °C or max RATED ambient])
fmax = maximum permitted temperature
NOTE 2 - Indicate insulation class (IEC 60085) under comments (optional)
TRF No. IEC61010 1L

IEC 61010-1
10.5.2 TABLE: Resistance to heat of non-metallic ENCLoSURES Form A.27 p

Test method used: —
Non-operative treatment......................................... HJ p
Empty ENCLOSURE.............................................. I] N/A
Operative treatment................................................ [] N/A
Temperature during tests........................................: —
Description Material Comments Verdict
70 °C ± 2 °C, 7 h Plastic enclosure: ABS No warping, cracking or p
breaking when subjected to
stresses of Cl. 8.2 & 8.3 within
10 minutes after the end of
treatment and passed the test
of Cl. 8.1
Dielectric strength test (6.8)........................................................... 3000 V [r.m.s.] p

NOTE - Within 10 minutes of the end of treatment suitable tests in acc. to 8.2 and 8.3 must be conducted and pass criteria of 8.1.
TRF No. IEC61010 1L

EPIOF'K Page 77 of 91 Report No. MEE202002154-01
IEC 61010-1
10.5.3 TABLE: Insulating material Form A.28 P

10.5.3 1) Ball-pressure test p
Max. allowed impression diameter.......................... 2 mm —•
Part Test temperature Impression diameter Verdict
[°C] [mm]
220 V terminal 125 1.5 P
10.5.3 2) Vicat softening test (ISO 306) Form A.29 N/A

Part Vicat softening temperature Thickness of sample Verdict
[°C] [mm]
— — — —
TRF No. IEC61010 1L

EPimteK Page 78 of 91 Report No. MEE202002154-01
IEC 61010-1
Clause [Requirement — Test |Result—Remark | Verdict"
8 TABLE: Mechanical resistance to shock and impact Form A.30 P

11 Protection against HAZARDS from fluids and solid foreign objects P
Voltage tests can be carried out once after performing the tests of clause 8 and clause 11. However, if voltage tests are carried out separately after each set of tests, two forms can be used
Clause 8 tests Clause 11 tests

Location Static Impact Normal Handheld Cleaning Spillage Overflow IEC Working Test Verdict Comments
(see Form (8.2.1) (8.2.2) (8.3.1) Plug-in (11.2) (113) (114) 60529 voltage voltage
A. 14) 30 N (8.3.2) (116) [V r m.s] [V r.m.s.]
A P P P N/A P N/A N/A N/A 240 1500 P
B P P P N/A P N/A N/A N/A 240 1500 P
C P P P N/A P N/A N/A N/A 240 1500 P
D P P P N/A P N/A N/A N/A 240 3000 P
E P P P N/A P N/A N/A N/A 240 3000 P
F P P P N/A P N/A N/A N/A 240 3000 P
NOTE - Use r.m.s , d c or peak to indicate the used test voltage
TRF No. IEC61010_1L

Attachment 1 of MEE202002154 02
IEC 61010-1
11.7.2 TABLE: Leakage and rupture at high pressure Form A.31 N/A
Part Maximum Test Leakage Deformation Burst Comments
permissible pressure
working
pressure
[MPa] [MPa] Yes / No Yes / No Yes / No
— — — — — — —
NOTE - see also Annex G with requirements for USA and Canada.
11.7.3 TABLE: Leakage from low-pressure parts Form A.32 N/A

Part Test Leakage Comments
pressure
[MPa] Yes / No
— — — —
TRF No. IEC61010 1L

EPiniaK Page 80 of 91 Report No. MEE202002154-01
IEC 61010-1
12.2.1 TABLE: Ionizing radiation Form A.33 N/A

12.2.1.2 Equipment intended to emit radiation N/A
Locations tested Measured values Verdict Comments
[pSv/h]
— — — —
12.2.1.3 Equipment not intended to emit radiation Form A.34 N/A

Max. allowed effective dose rate at 100 mm.......... 1 pSv/h —
Locations tested Measured values Verdict Comments
[pSv/h]
— — — —
TRFNo. IEC61010 1L
IEC 61010-1
12.5.1 TABLE: Sound level Form A.35 p

Locations tested Measured Calculated maximum sound
maximum sound power level
pressure level
dB(A)
At operator’s normal position
55 —
and at bystanders’ positions
12.5.2 TABLE: Ultrasonic pressure Form A.36 N/A

Locations tested Measured values Comments
[dB] [kHz]
At operator’s normal position — — —
At 1 m from the ENCLoSURE — — —
NOTE - No limit is specified at present, but a limit of 110 dB above the reference pressure value of 20 pPa is under consideration for
applicable frequencies between 20 kHz and 100 kHz.
TRF No. IEC61010_1L

EPinicK Page 82 of 91 Report No. MEE202002154-01
IEC 61010-1
13.2.2 TABLE: Batteries and battery charging Form A.37 p

Battery load and charging circuit diagram:
I
[1,7] VRTCl >
inr
o>
2
J25 —
CR2032 SMD
Battery type............................................................ Manganese dioxide lithium —

coin battery
Battery manufacturer/model/catalogue No........... Panasonic / CR2032 —
Battery ratings....................................................... 3.0 V, 225 mAh, 0.2 mA —
Reverse polarity installment test No extremely high temperature p
rise, no safety hazard
Single component failures Verdict
Component Open circuit Short circuit
— — —
1) Manganese dioxide lithium coin battery is used in the PCB of display module.
2) The battery is not intended to be replaced by the user.
TRFNo. IEC61010 1L
EPini^K Page 83 of 91 Report No. MEE202002154-01
IEC 61010-1
14.3 TABLE: Overtemperature protection devices Form A.38 P

Reliability test
Component Type Verdict Comments
(NOTE)
Thermal protector (BH-B2D) SR P Operated 200 times

NOTE:
NSR = non-self-resetting (10 times)
NR = non-resetting (1 time)
SR = self-resetting (200 times)
TRF No. IEC61010_1L

IEC 61010-1
Clause Requirement —Test Result — Remark Verdict
4.4.27 TABLE: MAINS transformer Form A.39 N/A

4.4.27.2 Short circuit N/A
14.6 MAINS transformers tested outside equipment N/A
Type.............................. —
Manufacturer................ —
Test in equipment N/A
Test on bench N/A
Test repeated inside equipment (see 14.6) N/A
Optional - Insulation class (IEC 60085) of the lowest rated winding.............. —
Winding identification
Type of Protector for winding (NoTE 1)
Elapsed time
Current, A primary
secondary
Winding temperature, °C primary
(see NoTE 2) secondary
Tissue paper / cheesecloth OK ?
(Pass / Fail)
Voltage tests (see NoTE 3)
Primary to secondary V
Primary to core V
Secondary to secondary V
Secondary to core V
Verdict
NOTE 1: Primary fuse - PF / ( ) A
Secondary fuse - SF / ( )A
Overtemperature protection - OP / ( ) °C
Impedance protection -Z
NOTE 2: Indicate method of measurement - TC = with thermocouple
- R = resistance method
If resistance method is used, record resistance in cold and warm condition in Form A.26B.
NOTE 3: Record the voltage applied and the type of voltage (r.m.s. / d.c. / peak) and
for results use NB = no breakdown or B = breakdown
TRF No. IEC61010 1L

EPinT^K Page 85 of 91 Report No. MEE202002154-01
IEC 61010-1
4.4.27 TABLE: MAINS transformer Form A.40 N/A

4.4.27.3 Overload tests (for MAINS transformers) N/A
14.6 MAINS transformers tested outside equipment N/A
Type................................. —
Manufacturer................... : —
Test in equipment N/A
Test on bench N/A
Test repeated inside equipment (see 14.6) N/A
Optional - Insulation class (IEC 60085) of the lowest rated winding............... —
Winding identification
Type of Protector for winding (NoTE 1)
Elapsed time
Current, A primary
secondary
Winding temperature, °C primary
(see NoTE 2) secondary
Tissue paper / cheesecloth OK ?
(Pass / Fail)
Voltage tests (see NoTE 3)
Primary to secondary V
Primary to core V
Secondary to secondary V
Secondary to core V
Verdict
NOTE 1: Primary fuse -PF/ ( ) A
Secondary fuse - SF / ( ) A
Overtemperature protection -OP/ ( ) °C
Impedance protection -Z
NOTE 2: Indicate method of measurement TC = with
thermocouple R =
resistance method
NOTE 3: If resistance method is used, record resistance in cold and warm condition in Form A.26B.
Record the voltage applied and the type of voltage (r.m.s. / d.c. / peak) and
for results use NB = no breakdown or B = breakdown
TRF No. IEC61010 1L

EPinraK Page 86 of 91 Report No. MEE202002154-01
IEC 61010-1
Clause | Requirement —Test | Result — Remark | VerdicT
14.8 | TABLE: Circuits used to limit TRANSIENT OVERVOLTAGES Form A.411 N/A
Circuit / Designation Overvoltage MAINS voltage Test voltage fcn fc fmax Ignited Safely Properly Verdict Comments
Category [V r.m s ] M [°C] rcj [°C] Yes / No suppressed functional
Yes/No Yes / No
— — — — — — — — — — — —
Test room ambient temperature:||CC
NOTE - tm = measured temperature
k = tr corrected (U-f.+ 40 °C or max RATED ambient)
UM = maximum permitted temperature
Conformity is checked by applying 5 positive and 5 negative impulses with the applicable impulse withstand voltage, spaced up to 1 min apart, from a hybrid impulse generator (see IEC 61180-1).
TRF No. IEC61010_1L

EPimaK Page 87 of 91 Report No. MEE202002154-01
IEC 61010-1
Annex H TABLE: Qualification of conformal coating Form A.42 N/A

for protection against pollution
Technical properties
Manufacturer —
Type —
Meet requirements of ANSI / UL 746E [yes / no] —
Manufacturer declaration of coating material [yes / no] —
Operating temperature of coating [ ]°C —
Comparative tracking index (CTI) [J —
Insulation resistance [ ]MQ —
Dielectric strength I IV —
UV resistance (if required) [yes / no] —
Flammability rating —
Preparation of the test specimens conducted [yes / no] —
Item Test conditioning Parameter Td Samples Verdict Comments
h 1 2 3 4 5 6
1 Cold 24
2 Dry heat 48
3 Rapid temp,
change
4 Damp heat 24
5 Adhesion of coating 5N
Visual inspection
6 Humidity 48
7 Insulation > 100 MQ
resistance
Visual inspection
NOTE Td = Test duration time
TRF No. IEC61010 1L

IEC 61010-1
TABLE: Additional or special tests conducted Form A.43 N/A

Clause and name of test Test type and condition Observed results —
— — — —
TRF No. IEC61010 1L

EPimSK Page 89 of 91 Report No. MEE202002154-01
IEC 61010-1
Clause [Requirement — Test [Result— Remari? | Verdict
TRF No. IEC61010_1L

GPimSK Page 90 of 91 Report No. MEE202002154-01
IEC 61010-1
Clause [Requirement— Test |Result—Remark | Verdict
[TABLE 1.A: List of components and circuits relied on for safety |P

Unique component Application/function Manufacturer / Type / model Technical data Standard Mark(s) of conformity
reference or location trademark (NOTE 2) evidence of acceptance
(NOTE 1) (NOTE 3 and 4)
DIN EN 60127-1 (VDE
0820-1 ):2015-12; EN
60127-1:2006+A1:2011
+A2.2015
IEC 60127-1:2006
Overcurrent protection IEC 60127-1:2006/
5*20 mm
Fuse Littelfuse Inc. 218-Serie(s) AMD1:2011 VDE 40013496
T1AL250V
IEC 60127-1:2006/
AMD2:2015
IEC 60127-2:2014
DIN EN 60127-2 (VDE
0820-2):2015-07; EN
60127-2:2014
Single-conductor,
SHENZHEN thermoplastic UL758,
Insulation wire JINRUIHUA WIRE & 1007 insulation. IEC TS 60695-11-21 ULE316944
CABLE CO., LTD. 16AWG, 80 °C. 300
Vac, VW-1
Working voltage: 5 V
± 0.25 V, Working Declaration of Conformity
EN 60950-1:2006+A1:
GUANGZHOU YOKO current: 168 mA,
Barcode scanner Barcode scanning YOKO-M3 2006+A11:2009+A1:2010 Certificate No.:
ELECTRON CO., LTD. Standby current: 72
mA, -20 °C to +A12:2011+A2:2013 CTL1501090072-SC
+55 °C, IP54
KINGBOARD
PCB - LAMINATES KB-6160 V-0, 130 °C IEC 60695-11-10 ULE123995
HOLDINGS LTD.
SHENZHEN WOER
600 V, 125 °C.
Heat shrinkable tubing - HEAT-SHRINKABLE - ANSI/UL 224 UL E203950
VW-1
MATERIAL CO.. LTD.
TRF No. IEC61010.1L

IEC 61010-1
Clause [Requirement —Test [Result—Remark | Verdict
[TABLE 1.A: List of components and circuits relied on for safety P

Unique component Application/functjon Manufacturer / Type / model Technical data Standard Markfs) of conformity
reference or location trademark (NOTE 2) evidence of acceptance
(NOTE 1) (NOTE 3 and 4)
KINGFA SCI & TECH
Plastic enclosure Protective barrier FRABS-518 ABS.1.6 mm.V-0 ANSI/UL 94 ULE171666
CO., LTD.
Allegro Microsystems DC 3.8 V to 24 V,
Hall sensor - A1104LLHLT IEC 61010-1 Evaluated in appliance
Inc. -40 °C to +150 °C
Shenzhen Raindi
Display module AP7350 DC 3.6 to 4.2 V IEC 61010-1 Evaluated in appliance
Technologies Co., Ltd.
Shenzhen Jialicheng
Heating module BT-MiniBC-
Technology DC 24 V, 0.5 A IEC 61010-1 Evaluated in appliance
Heat-V1.7
Development Co., Ltd.
Nominal voltage: 3
V, Nominal capacity:
225 mAh,
Continuous standard
load: 0.2 mA,
Lithium battery Memory battery Panasonic CR2032
Maximum abnormal UL1642 UL MH12210
charging cun-ent: 10
mA, Operating
temperature: -30 °C
to +60 °C
Collector-emitter IEC 60747-5-5:2007
voltage: 80 V IEC 60747-5-5:2007/
Isolation voltage: AMD1:2013
VDE
Optocoupler (U13) - Toshiba TLP291 3750 Vrms DIN EN 60747-5-5
(0884-5):2015-11; Certificate No.: 40009347
Operating
temperature range: EN 60747-5-5:2011;
-55 °C to+110’C A1:2015
NOTE -» 1 List all different manufacturers of the above components -> 4 asterisk indicates mark assuring agreed level of surveillance
-» 2 May include electrical, mechanical values
-» 3 List licence no or method of acceptance
END OF IEC/EN 61010-1 TEST REPORT
TRF No. IEC61010_1L

EPinKK Page 1 of 8 Attachment 1 of MEE202002154-01
Photo Document
Figure 1. Front view of Coagulation Analyzer
Figure 2. Rear view of Coagulation Analyzer

Page 2 of 8 Attachment 1 of MEE202002154-01
Figure 3. Left side view of Coagulation Analyzer
Figure 4. Right side view of Coagulation Analyzer

EPIflTOK Page 3 of 8 Attachment 1 of MEE202002154-01
Figure 5. Top view of Coagulation Analyzer
Figure 6. Top view of Coagulation Analyzer (with protective barrier of printer opened)
Figure 7. Bottom view of Coagulation Analyzer
Figure 8. Front view of Coagulation Analyzer (with upper cover opened)

EPiniOK Page 5 of 8 Attachment 1 of MEE202002154-01
Figure 9. Top view of MCU Board
Figure 10. Bottom view of MCU Board

EPIfiTfiK Page 6 of 8 Attachment 1 of MEE202002154-01
Figure 11. Top view of PSU
Figure 12. Bottom view of PSU

EPIfIT&K Page 7 of 8 Attachment 1 of MEE202002154-01
Figure 13. PCB of Display module
Figure 14. PCB of Detection module

Figure 15. Top view of Temperature Control Board
Figure 16. Bottom view of Temperature Control Board
END OF PHOTO DOCUMENT

IAS Test Report issued under the responsibility of:
ACCREDITED'
Testing Laboratory
Tl-700
EPini&K
TEST REPORT
IEC 61010-2-101
Safety requirements for electrical equipment for measurement, control
and laboratory use
Part 2-101: Particular requirements for in vitro diagnostic
(IVD) medical equipment
Report Number................................. MEE202002154-02

Date of issue.................................... June 2, 2Q20
Total number of pages..................... 11 pages, see page 3 for list of attachments
Testing Laboratory...........................
Address............................................ Building 4xNa55Q Fenhy Avenue, Wujiang District, Suzhou, China
Applicant’s name.............................. thejfang PushKangBiotechnology Co., Ltd.
Address............................................ C408, Science and Technology Innovation Park NO.398, Mahuan
Roaa>Binhaf>B^rea, 312366 Shaoxing, Zhejiang, PEOPLE'S
REPUBLIC75FCHINA
Test specification:
Standard........................................... EN 61010-2-101:2017
Test procedure................................. Testing
Non-standard test method............... None
Test Report Form IEC61010 2 101B
No........................ Test Report VDE Testing and Certification Institute
Form(s) Originator........ Master 2015-03
TRF...................................... onformity Assessment Schemes for Electrotechnical Equipment
All rights reserved.
Copyright © 2015 IEC System of C
and Components (IECEE System). jrCEE
in part for non-commercial purposes as long as the IECEE is acknowledged as
takes no responsibility for and will not assume liability for damages resulting from
This publication may be reproduced in whole laterial due to its placement and context.
copyright owner and source of the material. IE
the reader’s interpretation of the reproduced n
General disclaimer:
1) The test report is only valid for the sample delivered by client.
2) The test results presented in this report relate only to the object tested.
3) Any erasure or without specific testing seal the report is invalid.
4) This report shall not be reproduced, except in full, without the written approval of EPIN Suzhou Ltd.
5) Please apply for rechecking within 15 days after receiving the report if there is any objection.
EPinifiK
Test item description.......................
Coagulation Analyzer
Trade Mark........................................ :
PUSHING
Manufacturer.....................................: Zhejiang PushKang Biotechnology Co., Ltd.
C408, Science and Technology Innovation Park NO.398, Mahuan
REPUBLIC OF CHINA
Model/Type reference...................... MC100
Ratings.............................................. : 220-240 V, 50/60 Hz, 60 VA
Responsible Testing Laboratory (as applicable), testing procedure and testing location(s):
Testing Laboratory: EPIN Suzhou Ltd.

Testing location/ address............................: Building 4, No.558 Fenhu Avenue, Wujiang District,
Suzhou, China
Tested by (name, function, signature)........ Jason Zhou

/
/
Reviewed by (name, function, signature)..: Jesse Zhao
I
"LJ
Approved by (name, function, signature)..: Jay Shao

'✓
□ Associated CB Testing Laboratory:

Testing location/ address.............................:
□ Testing procedure: WMT/CTF Stage 1:
Tested by (name, function, signature)........:

□ Testing procedure: WMT/CTF Stage 2:

Tested by (name + signature)......................

□ Testing procedure:
SMT/CTF Stage 3 or 4:
Tested by (name, function, signature)........:

Supervised by (name, function, signature):
IEC61010_2_101B

List of Attachments (including a total number of pages in each attachment):
Attachment 1: Transport and storage test report (4 pages)
Summary of testing:
Tests performed (name of test and test clause): Testing location:

All relevant tests indicated in the standard EPIN Suzhou Ltd.
Building 4, No.558 Fenhu Avenue, Wujiang
District, Suzhou, China
Summary of compliance with National Differences:
£<] The product fulfils the requirements of IEC 61010-2-101:2015
IEC61010 2 101B
Copy of marking plate:
Coagulation Analyzer PUSHING

Model: MC100
Input: —220V-240V 50/60Hz 60VA
20XX-X
SN MC1001000
IVD C€
Zhejiang Push Kang Biotechnology Co., Ltd.

Add: C408, Science and Technology Innovation Park NO.398, Mahuan Road, Binhai
new Area, 312366 Shaoxing, Zhejiang, PEOPLE’S REPUBLIC OF CHINA
Warning label
Label on package
IEC61010 2 101B
EPiniOK Page 5 of 11
Test item particulars...............................................
Classification of installation and use.................... Desk-top, professional use
Supply Connection.................................................. Detachable cord set
Possible test case verdicts:
- test case does not apply to the test object............N/A
- test object does meet the requirement...................P (Pass)
- test object does not meet the requirement...........F (Fail)
Testing...................................................................... :
Date of receipt of test item...........................................March 16, 2020
Date (s) of performance of tests.................................March 16, 2020 to April 30, 2020
General remarks:
’’(See Enclosure #)" refers to additional information appended to the report.
"(See appended table)" refers to a table appended to the report.
Throughout this report a comma / [X] point is used as the decimal separator.
Manufacturer’s Declaration per sub-clause 4.2.5 of IECEE 02:

The application for obtaining a CB Test Certificate Yes
includes more than one factory location and a £3 Not applicable
declaration from the Manufacturer stating that the
sample(s) submitted for evaluation is (are)
representative of the products from each factory has
been provided.............................................................
When differences exist; they shall be identified in the General product information section.
Name and address of factory (ies)..............................Zhejiang PushKang Biotechnology Co., Ltd.
C408, Science and Technology Innovation Park
NO.398, Mahuan Road, Binhai new Area, 312366
Shaoxing, Zhejiang, PEOPLE’S REPUBLIC OF
CHINA
General product information:

See main report, Report No.: MEE202002154-01
IEC61010 2 101B
d- Page 6 of 11 Report No. MEE202002154-02

IEC 61010-2-101
5. MARKING AND DOCUMENTATION p

5.1.1 General p
Additional symbols cannot be confused with the p
international ones
5.1.2 Identification p
Equipment is identified by: —
a) Manufacturer’s name or trademark and address See copy of marking plate p
National regulation may require more details on the —
address
b) Model number, name or other means MC100 p
The equipment or packaging or the instructions for —
use include:
1) The serial-number or the batch code preceded Serial number marked p
by “LOT" symbol 102 of Table 1
2) i) Indication that the equipment is IVD See copy of marking plate p
medical equipment
ii) Indication that the equipment is self-test Not self-test IVD equipment N/A
IVD medical equipment
iii) Identification of detachable components N/A
3) Instructions for use requires that oPERAToR N/A
only use consumables within their expiration
date
Required by regulation, indicate name and N/A
address of the authorized representative of the
manufacturer
5.1.5 TERMINALS, connections and operating devices N/A
5.1.5.101 Gas and liquid connections No such connections N/A
For safety, equipment clearly marked near to —
connector on the equipment with:
a) Means of identifying which gas or liquid used; N/A
where no internationally recognized symbol
(including chemical formulae) exists, equipment
marked with symbol 14 of Table 1
b) Maximum permitted pressure, or alternatively N/A
symbol 14 of Table 1 used
5.1.101 Transport and storage P
Packaging of equipment labelled to indicate special See copy of marking plate P
conditions for transport or storage
5.3 Durability of markings P
The required markings resist the effects of (see Form A.3) P
temperature and rubbing, and of solvent and
reagents likely to be encountered in NoRMAL USE
IEC61010 2 101B
EPini&x Page 7 of 11
IEC 61010-2-101
Resistant also against agents specified by P

manufacturer for cleaning and decontamination
procedure
5.4 Documentation p
5.4.3 Equipment transportation, installation and assembly p
instructions
Documentation for the RESPoNSIBLE BoDY includes: —
a) Instructions for transportation after delivery to p
the RESPoNSIBLE BoDY
b) Floor loading requirements, mass and Desk-top equipment, no such N/A
dimensions are sufficient information requirements necessary
c) Individual mass of heavy units No such units N/A
d) Location and mounting instructions P
e) Assembly instructions P
f) Instructions for protective earthing P
g) The sound data required by 12.5.1 See main report, Cl. 12.5.1 N/A
h) Instructions relating to the handling, P
containment and exhaust of hazardous
substances
i) Any drainage systems required No such drainage systems N/A
j) Protective measures relating to HAZARDoUS P
radiation
k) Connections to the supply P
I) PERMANENTLY CoNNECTED EQUIPMENT only: Not permanently connected —
1) Mains supply requirements and details of N/A
connections
2) If external switch or circuit-breaker, N/A
requirements and location recommendation
m) Special services including pressure limits N/A
5.4.4 Equipment operation P
Instructions for use include: —
a) Details of operating controls P
b) Positioning for disconnection (see 6.11) P
c) Interconnection P
d) Specification of intermittent operation limits Continuous operation N/A
e) Explanation of symbols used P
f) Any actions to be taken by an OPERAToR to deal P
with HAZARDS
IEC61010_2_101B
EPiniaic Page 8 of 11 Report No. MEE202002154-02

IEC 61010-2-101
g) Cleaning and decontamination (see 11.2) incl. p

materials
h) Disposal of hazardous waste p
i) Hazardous chemical substances, use, need for p
training, or personal protection measures
j) Infectious substances, need to use personal Personal protective equipment p
protective equipment, e.g. gloves or gowns needed when handling
infectious substances
k) Hazardous vapours, instructions and No hazardous vapours N/A
requirements for protection of the mouth, nose
or eyes
I) Hazardous radiation, instructions and Not stare into beam of p
requirements for protective devices Barcode scanner
m) Instructions about RISK reduction procedures No flammable liquids used N/A
relating to flammable liquids (see 9.5 c))
n) Methods of reducing RISKS of burns from N/A
surfaces permitted to exceed temperature limits
of 10.1
o) Warnings to reduce RISK during loading and N/A
unloading of samples and reagents (see
7.3.102)
p) Instructions for RESPONSIBLE BODY that all p
retaining hardware in place on removable
PROTECTIVE BARRIERS and removable
PROTECTIVE BARRIERS in place on instrument
during normal operation
q) A statement for required TOOL to remove fixed N/A
PROTECTIVE BARRIER and/or ENCLOSURE
guarding a SAMPLE ZONE, access to that TOOL
controlled by RESPONSIBLE BODY
r) A statement listing the TOOLS controlled by N/A
RESPONSIBLE BODY
5.4.4.101 Instructions for use, self-test IVD medical Not self-test IVD equipment N/A
equipment
Instructions for use for self-test equipment comply N/A
with ISO 18113-5
5.4.101 Removal of equipment from use for repair or P
disposal
Instructions for the RESPONSIBLE BODY for —
eliminating or reducing HAZARDS includes:
Removal from use p
Transportation or disposal, or p
Appropriate contact information provided p
5.4.102 Transport and storage p
IEC61010 2 101B
EPinie-K Page 9 of 11
IEC 61010-2-101
Permissible environmental conditions for transport —

and storage of the equipment specified:
In documentation and P
Essential information on outside of package using See copy of marking plate P
appropriate symbols (see 5.1.101)
Manufacturer assumes responsibility for delivery N/A
and installation, above documentation not required
7 PROTECTION AGAINST MECHANICAL HAZARDS P

7.3.1 General P
Conditions specified in 7.3.4, 7.3.5 and 7.3.101 are P
considered to represent a tolerable level
7.3.2 Exceptions No such exceptions N/A
Warning markings prohibiting access by untrained N/A
OPERATORS, placed within the area requiring
maintenance and alert OPERATOR to the hazard
Alternative symbol 14 of Table 1 used, with N/A
warnings included in documentation
b) 4) OPERATOR maintenance instruction specify N/A
safe maintenance procedure
7.3.3 RISK assessment for mechanical HAZARDS to body Risk assessment report was P
parts checked
Risks reduced to a tolerable level by at least Interlock used, no P
applicable minimum protective measure of Table unacceptable risk
12, taking into account the severity, probability of
exposure and possibility of avoiding the HAZARD
7.3.101 SAMPLE ZONE P
Equipment with a SAMPLE ZONE comply with the —
requirements of one or more of the following:
aa) PROTECTIVE BARRIER Or P
bb) all following measures apply: —
1) Minimum maintained gap between LOADING N/A
ZONE and SAMPLE ZONE is 120 mm
2) Unintentional contact between OPERATOR N/A

and sample/reagent pipettor is unlikely
3) Area between LOADING ZONE and SAMPLE N/A
ZONE marked with symbols 14 and 101 of
Table 1 (see 5.4.4 o)), or if not visible by
OPERATOR marking located visible and is
close to the area
8 RESISTANCE TO MECHANICAL STRESSES P

8.1.101 Transport and storage See Attachment 1 P
IEC61010 2 101B

IEC 61010-2-101
Records of tests performed by the manufacturer Transport and storage test P

show conformity (Guidance ASTM D4169 of ISTA) report was checked
Manufacturer assumes for delivery and installation, N/A
the above requirement is met without inspection of
test records
13 PROTECTION AGAINST LIBERATED GASES AND SUBSTANCES, EXPLOSION P

AND IMPLOSION
13.101 Biohazardous substances p
Potentially infectious equipment due to samples or —
reagents marked with biohazard symbol 101 of
Table 1:
- Near sampling area, visible in NoRMAL USE p
A used
- Placed near biohazardous areas accessed p
during oPERAToR maintenance visible
- Marked on containers or bags for biohazardous N/A
waste material which can be removed from
equipment during NoRMAL USE
Equipment which becomes hazardous due to use N/A
of hazardous substances marked with appropriate
international symbol, or symbol 14 of Table 1
14 COMPONENTS AND SUBASSEMBLIES N/A

14.3 Over-temperature protection devices Not self-test IVD equipment N/A
Does not operate in NoRMAL USE N/A
Not self-resetting in self-test IVD equipment N/A
15 PROTECTED BY INTERLOCKS N/A

15.1 General N/A
Alternative method for interlock systems containing N/A
electric/electronic or programmable components
(E/E/P components), reliability and design
requirements determined by applying IEC 62061
(SIL) or ISO 13849 (PL) or other solutions with
equivalent functional safety
17 RISK ASSESSMENT P
RISK assessment carried out and documented in p
acc. to the requirements of ISO 14971 for HAZARDS
which not addressed in this standard and Part 1.
IEC61010 2 101B
EPiniax Page 11 of 11
IEC 61010-2-101
5.3 TABLE: Durability of markings Form A.3 P

Marking method (see NoTE) Agent
1) Adhesive label A Water
2) Ink printed B Isopropyl alcohol 70%
3) Laser marked C Specify agent: ethyl alcohol 95%
4) Film-coated (plastic foil control panel) D (specify agent)
5) Imprinted on plastic (moulded in) E (specify agent)
NOTE - Where applicable include print method, label material, ink or paint type,
fixing method, adhesive and surface to which marking is fixed.
Marking location Marking method (see above)

Identification (5.1.2) N/A, see main report
MAINS supply (5.1.3) N/A
Fuses (5.1.4) N/A
Terminals and operating devices (5.1.5.2) N/A
Switches and circuit breakers (5.1.6) N/A
Double/reinforced equipment (5.1.7) N/A
Field wiring Terminal boxes (5.1.8) N/A
Warning marking (5.2) 1), symbol 101 of Table 1
Battery charging (13.2.2) N/A
Method Test agent Remains legible Label loose Curled edges Comments
Verdict Verdict Verdict
1 A.C P P P —
None
END OF IEC/EN 61010-2-101 TEST REPORT
IEC61010 2 101B
Package Transport Test Report
1. Test purpose
By simulating the packaging and transportation environment, verify that the
packaging materials designed by Zhejiang Pushkang Biotechnology Co., Ltd. for
MC100 coagulation analyzer meet the requirements for transportation and storage.
2. Description of sample
Product name: Coagulation analyzer
Models: MC100
Sample quantity: 1
Size: 270mm x 180mm x 155mm
Weight: 3kg
Standard: ISTA 2A
Figure 1 Packing box before experiment
Figure 2 Sample before the experiment
3. Using equipment information

Table 1 Equipment information
Equipment name Equipment type Manufacturer
Vibration table HT-260T Dongguan Hui Tai Machinery Co., Ltd.
Hipot Tester CS2670A Nanjing Changsheng Instrument Co., Ltd
Leakage Current Tester CS2675X-1 Nanjing Changsheng Instrument Co., Ltd
Ground Resistance Tester CS2678 Nanjing Changsheng Instrument Co., Ltd
Version 1.0 Package Transport Test Report 1/3
4. Vibration test
Laboratory environment: temperature 25°C, humidity 56%.
4.1 Test method
Place the packaged instrument on the vibration test bench, fix the positioning device,
test according to the experimental parameters of Table 2 and Table 3, remove the
instrument after the test is completed, check whether the packaging is intact, and test
whether the instrument is working properly.
Table2 Test free uency and PSD
Frequency (Hz) PSD (g2/Hz)
1.0 0.0001
4.0 0.01
100.0 0.01
200.0 0.0001
Table3 Test time
No. Test time (min) Contact surface with vibration plane
1 90 Bottom surface
2 30 Top surface
3 30 Lateral surface
4 30 Frontal surface
4.2 Evaluation Criteria
4.2.1 Instrument packaging and appearance are in good condition with boot normal
after the test.
4.2.2 Withstand voltage test:
• Basic insulation: 1500V sine wave voltage test, lasting 5s, should not appear
breakdown or repeated arc
• Double insulation: 3000V sine wave voltage test, lasting 5 s, should not appear
breakdown or repeated arc
• Leakage current: test voltage AC 240V, normal working state (start-up),
0.5mA.
test voltage AC 240V, single fault state ( off ), < 3.5 mA.
Grounding Impedance between a protective conductor terminal and a
resistance: contactable component required for a protective connection
shall not exceed 0.IQ
4.3 Test process
The test situation is shown in Figure 3.

Figure 3: Test situation

4.4 Test result
After testing, the packaging of the instrument was not significantly damaged; the
appearance of the instrument was intact with boot normal, as shown in Fig. 4, 5. The
withstand voltage test results meet the requirements, and the test results are shown in
Table 4.
Figure 4: Packing box after test
Figure 5: Sample after test Table 4 Test result
Item Result
Withstand voltage test AC withstand voltage BI 1500V, DI / RI 3000V with in
good condition after 5 s
Leakage current test Leakage current 0.33mA
Grounding resistance test Grounding resistance 80.5mQ
5. Test Conclusion
The test results show that the packaging material of the product meets the
requirements of transportation.

2 Electrical Safety Test Report-MC100 - OCR

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Attachment 1 of MEE202002154-02

Informe de prueba emitido bajo la responsabilidad de:

Report Number.................................. MEE202002154-01

Applicant’s name.....................................<2bejiang PushKang Biotechnology Co., Ltd.

Page 2 of 91 Report No. MEE202002154-01

Test item description.........................: Coagulation Analyzer

Testing Laboratory: EPIN Suzhou Ltd.

Tested by (name, function, signature)............ Jason Zhou

Reviewed by (name, function, signature)...: Jesse Zhao

Approved by (name, function, signature)..: Jay Shao

□ Testing procedure: CTF Stage 1:

Tested by (name, function, signature)............:

□ Testing procedure: CTF Stage 2:

Tested by (name + signature)..........................

□ Testing procedure: CTF Stage 3:

□ Testing procedure: CTF Stage 4:

Tested by (name, function, signature)...........

Page 3 of 91 Report No. MEE202002154-01

List of Attachments (including a total number of pages in each attachment)

Document Documents included / attached to this report (description) Page

Documents referenced by this report (available on request):

Document Documents description Page

TRF No. IEC61010 1L

Page 4 of 91 Report No. MEE202002154-01

Test Report History:

Tests performed (name of test and test clause): Testing location:

Summary of compliance with National Differences:

TRF No. IEC61010_1L

EPI n TOK Page 5 of 91 Report No. MEE202002154-01

Copy of marking plate:

Coagulation Analyzer PUSHING

TRF No. IEC61010 1L

Page 6 of 91 Report No. MEE202002154-01

Test item particulars:

Possible test case verdicts:

Throughout this report a comma / KI point is used as the decimal separator.

EPfflf&K Page 7 of 91 Report No. MEE202002154-01

General product information and other remarks:

El escáner de código de barras no está evaluado según IEC 62471.

El equipo puede funcionar a máx. temperatura ambiente 30 °C y altitud hasta 2000 m.

TRF No. IEC61010 1L

Description of model differences:

Description of special features:

TRF No. IEC61010_1L

EPim^K Page 9 of 91 Report No. MEE202002154-01

4.4.1 Fault tests (see Form A.1) p

5 MARKING AND DOCUMENTATION p

TRF No. IEC61010 1L

Page 10 of 91 Report No. MEE202002154-01

Required equipment markings —

TRF No. IEC61010 1L

EPiniftK Page 11 of 91 Report No. MEE202002154-01

The maximum RATED current or power; or N/A

TRF No. IEC61010 1L

EPinF'K Page 12 of 91 Report No. MEE202002154-01

If push-button used as power supply switch: No push-button used —

Protected throughout (symbol 11 used) N/A

If TERMINAL or ENCLOSURE exceeds 60 °C: —

TRF No. IEC61010_1L

Page 13 of 91 Report No. MEE202002154-01

h) Instructions for lifting and carrying p

Page 14 of 91 Report No. MEE202002154-01

RATED energy level and test method stated N/A